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Background and Aim: More insight into the incidence of and factors associated with progression following a first episode of acute pancreatitis (AP) would offer opportunities for improvements in disease management and patient counseling., Methods: A long-term post hoc analysis of a prospective cohort of patients with AP (2008-2015) was performed. Primary endpoints were recurrent acute pancreatitis (RAP), chronic pancreatitis (CP), and pancreatic cancer. Cumulative incidence calculations and risk analyses were performed., Results: Overall, 1184 patients with a median follow-up of 9 years (IQR: 7-11) were included. RAP and CP occurred in 301 patients (25%) and 72 patients (6%), with the highest incidences observed for alcoholic pancreatitis (40% and 22%). Pancreatic cancer was diagnosed in 14 patients (1%). Predictive factors for RAP were alcoholic and idiopathic pancreatitis (OR 2.70, 95% CI 1.51-4.82 and OR 2.06, 95% CI 1.40-3.02), and no pancreatic interventions (OR 1.82, 95% CI 1.10-3.01). Non-biliary etiology (alcohol: OR 5.24, 95% CI 1.94-14.16, idiopathic: OR 4.57, 95% CI 2.05-10.16, and other: OR 2.97, 95% CI 1.11-7.94), RAP (OR 4.93, 95% CI 2.84-8.58), prior pancreatic interventions (OR 3.10, 95% CI 1.20-8.02), smoking (OR 2.33, 95% CI 1.14-4.78), and male sex (OR 2.06, 95% CI 1.05-4.05) were independently associated with CP., Conclusion: Disease progression was observed in a quarter of pancreatitis patients. We identified several risk factors that may be helpful to devise personalized strategies with the intention to reduce the impact of disease progression in patients with AP., (© 2024 The Authors. Journal of Gastroenterology and Hepatology published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)

Background: Many individuals without coeliac disease or wheat allergy reduce their gluten intake because they believe that gluten causes their gastrointestinal symptoms. Symptoms could be affected by negative expectancy. Therefore, we aimed to investigate the effects of expectancy versus actual gluten intake on symptoms in people with non-coeliac gluten sensitivity (NCGS)., Methods: This randomised, double-blind, placebo-controlled, international, multicentre study was done at the University of Leeds (Leeds, UK), Maastricht University (Maastricht, the Netherlands), and Wageningen University and Research (Wageningen, the Netherlands). People aged 18-70 years with self-reported NCGS (ie, gastrointestinal symptoms within 8 h of gluten consumption) without coeliac disease and wheat allergy were recruited. Participants had to follow a gluten-free or gluten-restricted diet for at least 1 week before (and throughout) study participation and had to be asymptomatic or mildly symptomatic (overall gastrointestinal symptom score ≤30 mm on the Visual Analogue Scale [VAS]) while on the diet. Participants were randomly assigned (1:1:1:1; blocks of eight; stratified by site and gender) to one of four groups based on the expectation to consume gluten-containing (E + ) or gluten-free (E - ) oat bread for breakfast and lunch (two slices each) and actual intake of gluten-containing (G + ) or gluten-free (G - ) oat bread. Participants, investigators, and those assessing outcomes were masked to the actual gluten assignment, and participants were also masked to the expectancy part of the study. The primary outcome was overall gastrointestinal symptom score on the VAS, which was measured at and corrected for baseline (before breakfast) and hourly for 8 h, with lunch served after 4 h, and analysed per-protocol. Safety analysis included all participants incorporated in the per-protocol analysis. The study is registered at ClinicalTrials.gov, NCT05779358, and has ended., Findings: Between Oct 19, 2018, and Feb 14, 2022, 165 people were screened and 84 were randomly assigned to E + G + (n=21), E + G - (n=21), E - G + (n=20), or E - G - (n=22). One person in the E + G + group was excluded due to not following test day instructions, leaving 83 participants in the per-protocol analysis. Median age was 27·0 years (IQR 21·0-45·0), 71 (86%) of 83 people were women, and 12 (14%) were men. Mean overall gastrointestinal symptom score was significantly higher for E + G + (16·6 mm [95% CI 13·1 to 20·0]) than for E - G + (6·9 mm [3·5 to 10·4]; difference 9·6 mm [95% CI 3·0 to 16·2], p=0·0010) and E - G - (7·4 mm [4·2 to 10·7]; difference 9·1 mm [2·7 to 15·6], p=0·0016), but not for E + G - (11·7 mm [8·3 to 15·1]; difference 4·9 mm [-1·7 to 11·5], p=0·28). There was no difference between E + G - and E - G + (difference 4·7 mm [-1·8 to 11·3], p=0·33), E + G - and E - G - (difference 4·2 mm [-2·2 to 10·7], p=0·47), and E - G + and E - G - (difference -0·5 mm [-7·0 to 5·9], p=1·0). Adverse events were reported by two participants in the E + G - group (itching jaw [n=1]; feeling lightheaded and stomach rumbling [n=1]) and one participant in the E - G + group (vomiting)., Interpretation: The combination of expectancy and actual gluten intake had the largest effect on gastrointestinal symptoms, reflecting a nocebo effect, although an additional effect of gluten cannot be ruled out. Our results necessitate further research into the possible involvement of the gut-brain interaction in NCGS., Funding: Government of the Netherlands Topsector Agri & Food Top Consortium for Knowledge and Innovation, AB Mauri Global Bakery Ingredients, Baking Industry Research Trust, Borgesius-Albert Heijn, CSM Innovation Centre, the International Maize and Wheat Improvement Center (CIMMYT), DSM Food Specialties, Fazer, Healthgrain Forum, the International Association for Cereal Science and Technology, the International Wheat Gluten Association, Lantmännen, Mondelez International, Nederlands Bakkerij Centrum, Nutrition & Santé, Puratos, Rademaker, Sonneveld Group, and Zeelandia HJ Doeleman., Competing Interests: Declaration of interests MCGdG, CLL, FC, MAMH, and GvR report partial financing by a public–private partnership grant from Topsector Agri & Food Top Consortium for Knowledge and Innovation (TKI) for Well on Wheat? (TKI16060BMNU). AS reports consulting fees and financial support for conference attendance from Owlstone Medical (all outside submitted work). PLW reports part employment by the European Bakery Innovation Centre, Sonneveld Group, who provided the study breads; Sonneveld Group received payment from a public–private partnership grant of TKI Well on Wheat? (TKI16060BMNU) for providing the study bread. PRS reports a public–private partnership grant of TKI Well on Wheat? (TKI16060BMNU), Agriculture and Horticulture Development Board Studentship Project grant (061), FIBRAXFUN grant, the Biotechnology and Biological Sciences Research Council (BBSRC) grant (BB/S013954/1, BBSRC BB/S020101/1, BBSRC BB/T013923/1, and BBSRC BB/W01792X/1), and the Engineering and Physical Sciences Research Council grant (EP/S01679/1 GCRF Hub SANC South Asian Nitrogen Hub); an honorarium for membership of the Editorial Board of the Journal of Cereal Science (Elsevier); payment for conference flight, hotel, and registration costs by Gluten Workshop Madrid, Wheat Research Updates Norway, 8th International Conference on Dietary Fiber, From Seed to Pasta IV, and the British Society for Allergy and Clinical Immunology; being a member of the Irish Department of Agriculture, Food and the Marine grant board (paid to self); and employment at Rothamsted Research, which receive strategic funding from the BBSRC and whose work forms part of the Designing Future Wheat (BB/P016855/1) and Developing Sustainable Wheat (BB/X011003/1) strategic programmes. LAH reports acting as a consultant to GSK, Ironwood, and non-paid to Pfizer; receiving financial support to attend the Rome V foundation meeting in Chicago, IL, USA, in May, 2023; and being a member of the British Society of Gastroenterology Neurogastroenterology and Motility Committee and Food and Function Committee (all outside submitted work). DK reports receiving research funding from Grunenthal, Allergan, ZonMw, MLDS, the Rome Foundation, Horizon 2020, Horizon Europe, and United European Gastroenterology; receiving a speaker's fee (paid to host institution) from Dr Falk; participating on a data safety and monitoring and advisory board for the NUTRECOVER study (no financial reimbursement); and being a board member of the Dutch Society of Gastroenterology (no financial reimbursement; all outside submitted work). FJPHB reports receiving a public–private partnership grant of TKI Well on Wheat? (TKI16060BMNU); consulting fees from Lesaffre France; a personal speaker fee and travel cost reimbursement from Zeelandia Netherlands; and payment from Zeelandia and Lesaffre for travel or hotel costs (paid to institution) for invited scientific meetings. LD reports partial financing by a public–private partnership grant of TKI Well on Wheat? (TKI16060BMNU); being a past President of the International Life Sciences Institute Europe and current Co-Chair of the International Life Sciences Institute Global; receiving grant funding from Sanofi Consumer Healthcare; and sitting on the Hass Avocado Scientific Advisory Board. DMAEJ reports receiving a public–private partnership grant of TKI Well on Wheat? (TKI16060BMNU) and TKI grants from Agri & Food and Health Holland (AF18109, LWV20.187, LWV21.052, LSHM22057), the Carbokinetics programme as part of the Netherlands Organisation for Scientific Research–Carbohydrate Competence Center partnership, Organic A2BV/Mothersfinest, and Horizon 2020 (DISCOvERIE/848228). All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Introduction: Physical activity has been suggested to alleviate gastrointestinal (GI) symptoms in patients with irritable bowel syndrome (IBS); however, evidence is scarce. Running has become increasingly popular and may be beneficial for patients with IBS. To obtain more insight in the potential application of running as therapy, we aimed to explore the impact of running and its intensity on GI symptoms in patients with IBS., Methods: Data from a large observational study in runners were used for this nested case-control study, which included 153 runners with IBS and 153 controls. All participants had completed a questionnaire on personal characteristics, running characteristics and GI symptoms. Regarding GI symptoms, the severity of nine symptoms was asked, both at rest and during and/or shortly (up to 3 h) after running. Each symptom could be scored on a scale from 0 (not bothersome) to 100 (very bothersome), resulting in a maximum total score of 900 points., Key Results: The prevalence and total severity score of GI symptoms were higher in runners with IBS than in controls, both at rest and during running. Among runners with IBS, the median (25th-75th percentile) total severity score during/after running was significantly lower than at rest (118 [50-200] vs. 150 [90-217]), while in controls no significant difference between running and rest was observed. Analyses stratified for running intensity revealed that the beneficial effect in runners with IBS was present when their most intensive training session was moderately intensive or intensive but not very intensive., Conclusions & Inferences: Running, particularly on moderate intensity, could have a beneficial effect on GI symptoms in patients with IBS., (© 2023 The Authors. Neurogastroenterology & Motility published by John Wiley & Sons Ltd.)

Emerging evidence suggests the gut microbiome's potential in predicting response to biologic treatments in patients with inflammatory bowel disease (IBD). In this prospective study, we aimed to predict treatment response to vedolizumab and ustekinumab, integrating clinical data, gut microbiome profiles based on metagenomic sequencing, and untargeted fecal metabolomics. We aimed to identify predictive biomarkers and attempted to replicate microbiome-based signals from previous studies. We found that the predictive utility of the gut microbiome and fecal metabolites for treatment response was marginal compared to clinical features alone. Testing our identified microbial ratios in an external cohort reinforced the lack of predictive power of the microbiome. Additionally, we could not confirm previously published predictive signals observed in similar sized cohorts. Overall, these findings highlight the importance of external validation and larger sample sizes, to better understand the microbiome's impact on therapy outcomes in the setting of biologicals in IBD before potential clinical implementation.

Study Design: Retrospective Observational Study., Objectives: To describe bowel management in individuals with a recently acquired spinal cord injury (SCI) both at admittance and discharge from first inpatient rehabilitation, and to determine factors that contribute to effective bowel management (EBM) at discharge., Setting: Specialized rehabilitation centers in the Netherlands., Methods: Data from the Dutch Spinal Cord Injury Database (DSCID) collected between 2015 and 2019 was used. EBM was defined by the variables of stool frequency and fecal incontinence. After univariate analysis, a multivariate regression analysis was conducted., Results: Of 1,210 participants, 818 (68%) did not have EBM at admittance. At discharge, 308 (38%) did still not have EBM (in total 33% of all participants). The odds of having EBM at discharge was 2.82 times higher for participants with ASIA Impairment Scale (AIS) D compared to those with AIS-A (95% CI: 1.38-5.78). Participants with non-traumatic SCI had higher odds of having EBM than those with traumatic SCI (OR: 0.59, 95% CI 0.38-0.91). Use of suppositories, small enema, medication influencing bowel function, and oral laxatives at admittance did not influence EBM significantly at discharge., Conclusions: Bowel management improves during first inpatient rehabilitation. However, realizing EBM after a recently acquired SCI is a challenge. This endorses the importance of bowel management during inpatient rehabilitation, especially for people with AIS-A and non-traumatic etiology., (© 2023. The Author(s), under exclusive licence to International Spinal Cord Society.)

Objectives: Abdominal complaints (AC) during exercise are a common problem in runners. Nutrition is known to play a role in exercise-related AC, but information on the role of habitual dietary intake is limited. We assessed the prevalence of AC in a large cohort of runners, and investigated its association with potential risk factors, with a particular focus on nutritional factors in the habitual diet., Methods: A total of 1993 runners completed two online questionnaires: a general questionnaire on, among others, running habits and exercise-related AC and a Food Frequency Questionnaire. Runners with and without either upper AC (UAC) or lower AC (LAC) were compared regarding personal characteristics, running characteristics and habitual dietary intake., Results: 1139 runners (57%) reported AC during and/or up to 3 hours after running: 302 runners (15%) reported UAC, 1115 (56%) LAC and 278 (14%) both. In about one-third of runners with AC, these complaints negatively affected their running. Exercise-related AC were positively associated with female gender, younger age and more intense running. Most associations with nutritional factors were observed only for LAC in men, with a higher intake of energy, all macronutrients and grain products in men with LAC. In both men and women, a higher intake of tea and unhealthy choices were associated with AC., Conclusion: Exercise-related AC were quite prevalent, and in about one-third of the cases, AC impacted their running. Being female, having a younger age and running at higher intensity were positively associated with AC. Some aspects of the habitual diet were associated with AC. Most notable were positive associations for intake of fat, tea and unhealthy choices., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Lower limb tendinopathy (LLT) is highly prevalent in runners. Treatment can be challenging, and knowledge of risk factors may be valuable to develop preventive or treatment interventions for LLT. The aims of this study were (1) to assess the prevalence of three common LLTs (Achilles tendinopathy (AT), patellar tendinopathy and plantar fasciopathy) in a large cohort of Dutch and Belgian runners and (2) to investigate its association with potential risk factors, with a particular focus on nutritional factors in the habitual diet., Methods: A total of 1993 runners were included in the study. They completed two online questionnaires: a general questionnaire on running habits and injuries and a Food Frequency Questionnaire. Runners with and without LLT were compared regarding personal characteristics, running characteristics and nutritional factors., Results: The point prevalence for the three LLTs was 6%; 33% of the runners reported LLT in the past and 35% had either a current or past LLT. AT was the most prevalent type of LLT, and prevalence rates for all types of LLT were higher in men than women. Positive associations with LLT were observed for age and running years (men and women), running level and running distance (men). No associations between LLT and nutritional factors were observed., Conclusion: One-third of this population of runners had ever experienced an LLT. These tendinopathies were associated with gender, age and running load, but not with nutritional factors., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background & Aims: Discontinuation of anti-tumor necrosis factor-α treatment (anti-TNF) (infliximab and adalimumab) in patients with inflammatory bowel disease (IBD) is associated with a high relapse risk that may be influenced by endoscopic activity at the time of stopping. We assessed the relapse rate after anti-TNF withdrawal in patients with endoscopic healing and studied predictors of relapse including the depth of endoscopic healing., Methods: This was a multicenter, prospective study in adult patients with Crohn's disease (CD), ulcerative colitis (UC), or IBD-unclassified (IBDU), with ≥6 months of corticosteroid-free clinical remission (confirmed at baseline) and endoscopic healing (Mayo <2/SES-CD <5 without large ulcers), who discontinued anti-TNF between 2018 and 2020 in the Netherlands. We performed Kaplan-Meier and Cox regression analyses to assess the relapse rate and evaluate potential predictors: partial (Mayo 1/SES-CD 3-4) versus complete (Mayo 0/SES-CD 0-2) endoscopic healing, anti-TNF trough levels, and immunomodulator and/or mesalamine use., Results: Among 81 patients (CD: n = 41, 51%) with a median follow-up of 2.0 years (interquartile range, 1.6-2.1), 40 patients (49%) relapsed. Relapse rates in CD and UC/IBDU patients were comparable. At 12 months, 70% versus 35% of patients with partial versus complete endoscopic healing relapsed, respectively (adjusted hazard rate [aHR], 3.28; 95% confidence interval [CI], 1.43-7.50). Mesalamine use was associated with fewer relapses in UC/IBDU patients (aHR, 0.08; 95% CI, 0.01-0.67). Thirty patients restarted anti-TNF, and clinical remission was regained in 73% at 3 months., Conclusions: The relapse risk was high after anti-TNF withdrawal in IBD patients with endoscopic healing, but remission was regained in most cases after anti-TNF reintroduction. Complete endoscopic healing and mesalamine treatment in UC/IBDU patients decreased the risk of relapse., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Endoscopic retrograde cholangiopancreatography (ERCP) is the procedure of choice to remove sludge/stones from the common bile duct (CBD). In a small but clinically important proportion of patients with suspected choledocholithiasis ERCP is negative. This is undesirable because of ERCP associated morbidity. We aimed to map the diagnostic pathway leading up to ERCP and evaluate ERCP outcome., Methods: We established a prospective multicenter cohort of patients with suspected CBD stones. We assessed the determinants that were associated with CBD sludge or stone detection upon ERCP., Results: We established a cohort of 707 patients with suspected CBD sludge or stones (62% female, median age 59 years). ERCP was negative for CBD sludge or stones in 155 patients (22%). Patients with positive ERCPs frequently had pre-procedural endoscopic ultrasonography (EUS) or magnetic resonance cholangiopancreatography (MRCP) imaging (44% vs. 35%; P = 0.045). The likelihood of ERCP sludge and stones detection was higher when the time interval between EUS or MRCP and ERCP was less than 2 days (odds ratio 2.35; 95% CI 1.25-4.44; P = 0.008; number needed to harm 7.7)., Conclusions: Even in the current era of society guidelines and use of advanced imaging CBD sludge or stones are absent in one out of five ERCPs performed for suspected CBD stones. The proportion of unnecessary ERCPs is lower in case of pre-procedural EUS or MRCP. A shorter time interval between EUS or MRCP increases the yield of ERCP for suspected CBD stones and should, therefore, preferably be performed within 2 days before ERCP., (© 2022. The Author(s).)

Hydrogenotrophic microbes, primarily including the three functional groups methanogens, sulfate-reducing bacteria, and reductive acetogens, use hydrogen as an energy source and play an important role in maintaining the hydrogen balance in gut ecosystems. A distorted hydrogen balance has been associated with irritable bowel syndrome (IBS). However, the role of hydrogenotrophic microbes in overall microbiota composition and function remains largely unknown. This study aims to assess the distribution and stability of hydrogenotrophic functional groups in healthy adults (HAs) and IBS patients and their association with overall microbiota composition and IBS symptoms. A two-time-point study with 4 weeks in between was performed with 27 HAs and 55 IBS patients included. Our observations revealed that methanogens showed a bimodal distribution across samples. A high-level methanogen microbiota was consistently associated with higher alpha diversity, and its composition was significantly different from that of individuals with a low-level methanogen microbiota. In general, these associations were more pronounced in IBS patients than in HAs. The differences in the copy numbers of genes indicative of total bacteria and acetogens between HAs and IBS patients and their correlations with IBS symptom severity, anxiety, depression, and quality of life (QoL) were sampling time dependent. Hydrogenotrophic functional groups did not show negative abundance correlations with each other in HAs and IBS patients. These findings suggest that methanogen levels in the gut have a pronounced association with microbiota alpha diversity and composition, and the interactions between hydrogenotrophic functional groups are complex in gut ecosystems. IMPORTANCE Hydrogenotrophic microbes play an essential role in the disposal of hydrogen and the maintenance of the hydrogen balance in gut ecosystems. Their abundances vary between individuals and have been reported to be associated with human gut disorders such as irritable bowel disease. This study confirms that methanogen levels show a bimodal distribution. Moreover, a high-level methanogen microbiota was associated with higher alpha diversity, and its composition was different from that of individuals with a low-level methanogen microbiota. These associations are more pronounced in IBS patients than in healthy subjects. In addition, associations between hydrogenotrophic microbes and IBS symptom scores vary over time, which argues for the use of longitudinal study designs. Last but not least, this study suggests that the different hydrogenotrophic microbes coexist with each other and do not necessarily compete for hydrogen in the gut. The findings in this study highlight the impact of methanogens on overall microbiota composition and function.

Background: Despite the potential benefits of diet and physical activity, evidence for beneficial effects of a combined lifestyle intervention is lacking in patients with inflammatory bowel disease (IBD). Therefore, we assessed its effects on impact of disease on daily life, clinical disease activity, fatigue, and health-related quality of life (HRQoL) in patients with IBD., Methods: A 6-month single-arm intervention study was performed in adult IBD patients in remission or with mildly active disease. Participants received personal dietary and physical activity advice from a dietician and a physiotherapist in 6 consults. At baseline and over time, questionnaires on diet quality, physical activity, and disease-related outcomes were completed and fecal calprotectin was determined. Data were analyzed by linear mixed models., Results: During the intervention, diet quality significantly increased (P < .001), but the level of physical activity remained the same. Over time, impact of the disease on daily life reduced (P = .009) and fatigue decreased (P = .001), while clinical disease activity, HRQoL, and fecal calprotectin did not change. Improvement in diet quality was significantly associated with a lower impact of disease on daily life (β = 0.09; 95% confidence interval [CI], 0.03 to 0.15; P = .003) and less fatigue (β = -0.13; 95% CI, -0.20 to -0.07; P < .001) but not with clinical disease activity, HRQoL, and fecal calprotectin. No associations were found with physical activity., Conclusions: This combined lifestyle intervention significantly improved diet quality, and this improvement was associated with a reduction in the impact of disease on daily life and fatigue in patients with IBD in remission or with mildly active disease., (© 2022 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation.)

Background: Irritable bowel syndrome (IBS) is the most prevalent functional bowel disorder, but its pathophysiology is still unknown. Although a microbial signature associated with IBS severity has been suggested, its association with IBS severity still remains largely unknown., Aims: This study aims to assess longitudinal dynamics of fecal microbiota and short-chain fatty acids (SCFAs) in different IBS severity groups and study the association with stool pattern, diet, depression, anxiety, and quality of life (QoL)., Methods: A longitudinal study was performed, including n = 91 IBS patients and n = 28 matched controls. All participants collected fecal samples for microbiota composition and SCFA analysis and completed validated questionnaires regarding IBS severity, stool pattern, depression, anxiety, and IBS-QoL at two timepoints with four weeks in-between. Diet was assessed at the first timepoint., Results: Over time, 36% of IBS patients changed in severity group, and 53% changed in predominant stool pattern. The largest proportion of microbiota variation was explained by the individual (R 2  = 70.07%). Microbiota alpha diversity and composition, and SCFAs did not differ between IBS severity groups, nor between IBS and controls. Relative abundances of Bifidobacterium, Terrisporobacter, and Turicibacter consistently differed between IBS and controls, but not between IBS severity groups. Large dynamics over time were observed in the association of microbiota composition with questionnaire data where IBS symptom severity was associated at T1 but not at T2., Conclusions: Fecal microbiota and SCFA signatures were not consistently associated with IBS severity over time, indicating the importance of repeated sampling in IBS research., (© 2022. The Author(s).)

This study evaluated the applicability and efficacy of patient education regarding fasting recommendations to shorten fasting times in patients undergoing esophagogastroduodenoscopy (EGD). A prospective nonrandomized controlled pilot study was performed. The intervention group (IG) was educated by nurses to eat until 6 hours and drink until 2 hours before EGD. The control group (CG) received usual care. Outcomes were applicability as perceived by patients, adherence to fasting recommendations, gastric visibility, and patients' comfort. A total of 109 patients were included of whom 42 were IG patients (37%). Patients' perspectives on fasting, their experienced discomfort, professional support, and circadian rhythm influenced application of fasting recommendations. Adherence to length of fasting from foods improved with 3:14 hours ( p < .001) and from liquids with 5:22 hours ( p < .001) in the IG compared with the CG. Gastric visibility during EGD was better in the IG than in the CG. The IG patients experienced significant less thirst, hunger, headache, and anxiety. To successfully reduce fasting times, fasting education should include positive, individual instructions, which help patients apply the fasting recommendations within their biorhythm. Positive, concrete instructions by nurses shortened fasting times before EGD, which improved gastric visibility and reduced patient discomfort., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Gastroenterology Nurses and Associates.)

Background & Aims: Previous randomized trials, including the Transluminal Endoscopic Step-Up Approach Versus Minimally Invasive Surgical Step-Up Approach in Patients With Infected Pancreatic Necrosis (TENSION) trial, demonstrated that the endoscopic step-up approach might be preferred over the surgical step-up approach in patients with infected necrotizing pancreatitis based on favorable short-term outcomes. We compared long-term clinical outcomes of both step-up approaches after a period of at least 5 years., Methods: In this long-term follow-up study, we reevaluated all clinical data on 83 patients (of the originally 98 included patients) from the TENSION trial who were still alive after the initial 6-month follow-up. The primary end point, similar to the TENSION trial, was a composite of death and major complications. Secondary end points included individual major complications, pancreaticocutaneous fistula, reinterventions, pancreatic insufficiency, and quality of life., Results: After a mean follow-up period of 7 years, the primary end point occurred in 27 patients (53%) in the endoscopy group and in 27 patients (57%) in the surgery group (risk ratio [RR], 0.93; 95% confidence interval [CI], 0.65-1.32; P = .688). Fewer pancreaticocutaneous fistulas were identified in the endoscopy group (8% vs 34%; RR, 0.23; 95% CI, 0.08-0.83). After the initial 6-month follow-up, the endoscopy group needed fewer reinterventions than the surgery group (7% vs 24%; RR, 0.29; 95% CI, 0.09-0.99). Pancreatic insufficiency and quality of life did not differ between groups., Conclusions: At long-term follow-up, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing death or major complications in patients with infected necrotizing pancreatitis. However, patients assigned to the endoscopic approach developed overall fewer pancreaticocutaneous fistulas and needed fewer reinterventions after the initial 6-month follow-up. Netherlands Trial Register no: NL8571., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders. Its pathophysiology is diverse and variable, involving disturbed gut-brain interactions, altered motility and secretion, visceral hypersensitivity, increased intestinal permeability, immune activation, and changes in gut microbiota. Complaints experienced by patients suffering from IBS and its co-morbidities strongly impair quality of life (QoL), and available treatments are often unsatisfactory. Anecdotal reports and preclinical data suggest that the endocannabinoid system and functionally related mechanisms could offer treatment targets. Cannabidiol (CBD) is a candidate agent of interest with a broad molecular target profile and the absence of psychoactive properties. Materials and Methods: In 32 female IBS patients, we explored the effect of a chewing gum formulation containing 50 mg CBD on abdominal pain and perceived well-being in a randomized, double-blinded, placebo-controlled cross-over trial. Chewing gums were used on-demand guided by pain symptoms with a maximum of six per day. Pain intensity was assessed by a visual analogue scale (scale 0.0-10.0), and QoL was evaluated with the IBS-36 questionnaire. Results: There was no statistically significant difference in pain scores between CBD and placebo at a group level. Subgroup and individual analyses showed a highly variable picture. No indications were found for symptom-driven intake, which also remained lower than expected overall. Conclusions: With the current design, based on the assumption that IBS patients would adjust their intake to their perceived symptom relief, no differences at the group level were found between CBD and placebo gum in pain scores and the number of gums used. The low use of the gums also indicates that the benefits experienced by these patients generally did not outweigh practical disadvantages such as prolonged chewing throughout the day. The very high intra- and inter-individual variation in IBS symptoms warrant future trials that are more personalized, for example by applying an N-of-1 (rotating) design with individualized dose titration.

Time to evaluate diet quality and give dietary advice is limited in clinical IBD practice. The Eetscore is a web-based tool that assesses diet quality according to the Dutch dietary guidelines and provides personalised dietary advice. We aimed to assess diet quality of IBD patients using the Eetscore and to study changes in diet quality, health-related quality of life (HRQoL) and clinical disease activity over time. A prospective cohort study was performed in 195 adult IBD patients. Participants were invited to fill out questionnaires (Eetscore-FFQ, short IBDQ and p-HBI/p-SCCAI) at baseline and after 1 and 4 months. The Eetscore calculates diet quality based on 16 food components (10 points per component, total score 0-160; the higher the better) and provides dietary advice per component based on the assessment. At baseline, mean diet quality was 98±19. Diet quality was positively associated with age, female gender and level of education. Component scores were highest for red meat, wholegrain products, and sweetened beverages, and lowest for legumes, nuts, and processed meat. Over time, diet quality increased to 107±21 at 4 months (p<0.001). Each 10-point improvement in diet quality was associated with an increase in HRQoL (β=0.4 (95%CI 0.02; 0.7), p=0.04). Clinical disease activity did not change. In conclusion, diet quality of IBD patients significantly improved following personalised dietary advice of the Eetscore. Improvement of diet quality was associated with a slight improvement in HRQoL. The Eetscore is a practical and useful tool to monitor and support a healthy diet in IBD patients.

Background: Health effects of dietary fibres are the topic of many studies. Eligibility criteria often include a certain fibre intake, which requires dietary screening during recruitment. However, dietary assessment methods are extensive and burdensome for both the researcher and participant. Therefore, we developed and validated a short questionnaire (FiberScreen) to screen fibre intake., Methods: The initial five-item questionnaire assessed fruit, vegetable, whole grain, pasta/rice/potato and legume intake. The optimised FiberScreen included 18 items, which further specified intake of the above-mentioned categories, and included nuts and seeds. The FiberScreen was completed during two fibre promoting interventions. In Study A, participants without constipation completed the five-item FiberScreen and a food frequency questionnaire (FFQ) during screening (n = 131), and the 18-item FiberScreen and a FFQ at 3-month follow-up (n = 87). In Study B, 29 constipated participants completed the 18-item FiberScreen at screening and a FFQ during the first study visit., Results: The fibre estimate from the five-item FiberScreen and the FFQ was moderately correlated (r = 0.356, p < 0.001). Importantly, the 18-item FiberScreen and FFQ, when data of both studies were combined, had a strong correlation (r = 0.563, p < 0.001). The 18-item FiberScreen had a lower fibre estimate compared to the FFQ (Δ = 1.2 ± 5.9 g, p = 0.030) but the difference was relatively small. Bland-Altman plots showed a good agreement between the questionnaires. Completion time of the 18-item FiberScreen was 4.2 ± 2 min., Conclusions: The 18-item FiberScreen is a suitable short screening questionnaire for ranking the fibre intake of adults. The 18-item FiberScreen can help to reduce screening burden for both the participant and researcher., (© 2021 The Authors. Journal of Human Nutrition and Dietetics published by John Wiley & Sons Ltd on behalf of British Dietetic Association.)

Background: Irritable Bowel Syndrome (IBS) is a prevalent, chronic gastrointestinal disorder that imposes a substantial socioeconomic burden. Peppermint oil is a frequently used treatment for IBS, but evidence about cost-effectiveness is lacking., Objective: We aimed to assess cost-effectiveness of small-intestinal release peppermint oil versus placebo in IBS patients., Methods: In a multicenter randomized placebo-controlled trial, cost-effectiveness was evaluated from a societal perspective. The incremental cost-effectiveness ratios (ICERs) were expressed as (1) incremental costs per Quality Adjusted Life Years (QALY), and (2) incremental costs per successfully treated patient, that is per abdominal pain responder (according to FDA definitions), both after an eight-week treatment period with placebo versus peppermint oil. Cost-utility and uncertainty were estimated using non-parametric bootstrapping. Sensitivity analyses were performed., Results: The analysis comprised 126 patients (N = 64 placebo, N = 62 small-intestinal release peppermint oil). Peppermint oil was a dominant treatment compared to placebo in 46% of bootstrap replications. Peppermint oil was also more effective but at higher cost in 31% of replications. The net-benefit acceptability curve showed that peppermint oil has a 56% probability of being cost-effective at a conservative willingness-to-pay threshold of €10.000/QALY. Peppermint oil was also a dominant treatment per additional successfully treated patient according to FDA definitions, that is in 51% of replications. In this case, the acceptability curve showed an 89% probability of being cost-effective., Conclusions: In patients with IBS, small-intestinal release peppermint oil appears to be a cost-effective treatment although there is uncertainty surrounding the ICER. When using abdominal pain responder as outcome measure for the ICER, peppermint oil has a high probability of being cost-effective. The use of peppermint oil, which is a low-cost treatment, can be justified by the modest QALY gains and slightly higher proportion of abdominal pain responders. More research and long-term data are necessary to confirm the cost-effectiveness of peppermint oil. NCT02716285., (© 2021 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC. on behalf of United European Gastroenterology.)

Background: Diet plays an important role in symptom management of irritable bowel syndrome (IBS). However, current diet therapies are not optimal nor successful for everyone., Objective: To investigate whether subgroups based on IBS subtypes or severity identify different self-reported dietary triggers, and whether these are associated with severity and psychological factors., Design: Online cross-sectional survey PARTICIPANTS: Patients with IBS (n = 1601) who fulfilled the Rome IV criteria or had an IBS diagnosis., Main Outcomes: Self-reported response to 44 preselected dietary triggers, IBS quality of life, and anxiety and depression. Subgroups were based on subtypes or severity., Statistical Analysis: Response to dietary triggers was analyzed using multiple correspondence analysis. Moreover, a food score was calculated to quantify the number and severity of responses to dietary triggers., Results: Response to greasy foods, onions, cabbage, and spicy and fried foods were mentioned most often (ranging between 55% and 65%). Response to dietary triggers differed between subtypes and severity groups, but absolute differences were small. Multiple correspondence analysis did not reveal clustering between dietary triggers, and ellipses for the subtypes overlapped. Some clustering was seen when ellipses were drawn for severity, which indicates that severity explained a fraction of the variation in response to dietary triggers, and subtypes did not. The food score was not significantly different between subtypes but was significantly higher with higher levels of severity (mild = 20.9 ± 17, moderate = 29.2 ± 19, severe = 37.9 ± 20, P < .001), having depressive (no = 31.4 ± 20, yes = 37.4 ± 20, P < .001) or anxious symptoms (no = 30.7 ± 20, yes = 35.2 ± 20, P < .001), and lower quality of life (lower quality of life = 38.5 ± 19, higher quality of life = 26.5 ± 19, P < .001)., Conclusion: Patients with different IBS subtypes or IBS severity do not identify different self-reported dietary triggers. Patients with more severe IBS and who experience anxiety or depression tend to have severe responses to more dietary triggers. IBS severity seems a better classifier than Rome IV criteria regarding diet. Dietary treatment needs to be individualized under guidance of a dietitian., (Copyright © 2021 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)

Background: Since 1999, international guidelines recommend fasting from solid foods up to 6 hours and clear liquids up to 2 hours before surgery. Early recovery after surgery programs recommend restoration of oral intake as soon as possible. This study determines adherence to these guidelines up to 20 years after its introduction., Methods: A 2-center observational study with a 10-year interval was performed in the Netherlands. In period 1 (2009), preoperative fasting time was observed as primary outcome. In period 2 (2019), preoperative fasting and postoperative restoration of oral intake were observed. Fasting times were collected using an interview-assisted questionnaire., Results: During both periods, 311 patients were included from vascular, trauma, orthopedic, urological, oncological, gastrointestinal, and ear-nose-throat and maxillary surgical units. Duration of preoperative fasting was prolonged in 290 (90.3%) patients for solid foods and in 208 (67.8%) patients for clear liquids. Median duration of preoperative fasting from solid foods and clear liquids was respectively 2.5 and 3 times the recommended 6 and 2 hours, with no improvements from one period to another. Postoperative food intake was resumed within 4 hours in 30.7% of the patients. Median duration of perioperative fasting was 23:46 hours (interquartile range 20:00-30:30 hours) for solid foods and 11:00 hours (interquartile range 7:53-16:00 hours) for clear liquids., Conclusion: Old habits die hard. Despite 20 years of fasting guidelines, surgical patients are still exposed erroneously to prolonged fasting in 2 hospitals. Patients should be encouraged to eat and drink until 6 and 2 hours, respectively, before surgery and to restart eating after surgery., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Prophylactic rectal administration of non-steroidal anti-inflammatory drugs (NSAIDs) is considered as standard of care to reduce the risk of post-ERCP pancreatitis. It has been suggested that aggressive hydration might further reduce this risk. Guidelines already recommend aggressive hydration in patients who are unable to receive rectal NSAIDs, although it is laborious and time consuming. We aimed to evaluate the added value of aggressive hydration in patients receiving prophylactic rectal NSAIDs., Methods: FLUYT, a multicentre, open-label, randomised, controlled trial done across 22 Dutch hospitals, included patients aged between 18 and 85 years with moderate to high risk of post-ERCP pancreatitis. Patients were randomly assigned (1:1) by a web-based module with varying block sizes to a combination of aggressive hydration and rectal NSAIDs (100 mg diclofenac or indomethacin; aggressive hydration group) or rectal NSAIDs (100 mg diclofenac or indomethacin) alone (control group). Randomisation was stratified according to treatment centre. Aggressive hydration comprised 20 mL/kg intravenous Ringer's lactate solution within 60 min from the start of ERCP, followed by 3 mL/kg per h for 8 h. The control group received normal intravenous saline with a maximum of 1·5 mL/kg per h and 3 L per 24 h. The primary endpoint was post-ERCP pancreatitis and was analysed on a modified intention-to-treat basis (including all patients who underwent randomisation and an ERCP and for whom data regarding the primary outcome were available). The trial is registered with the ISRCTN registry, ISRCTN13659155., Findings: Between June 5, 2015, and June 6, 2019, 826 patients were randomly assigned, of whom 388 in the aggressive hydration group and 425 in the control group were included in the modified intention-to-treat analysis. Post-ERCP pancreatitis occurred in 30 (8%) patients in the aggressive hydration group and in 39 (9%) patients in the control group (relative risk 0·84, 95% CI 0·53-1·33, p=0·53). There were no differences in serious adverse events, including hydration-related complications (relative risk 0·99, 95% CI 0·59-1·64; p=1·00), ERCP-related complications (0·90, 0·62-1·31; p=0·62), intensive care unit admission (0·37, 0·07-1·80; p=0·22), and 30-day mortality (0·95, 0·50-1·83; p=1·00)., Interpretation: Aggressive periprocedural hydration did not reduce the incidence of post-ERCP pancreatitis in patients with moderate to high risk of developing this complication who routinely received prophylactic rectal NSAIDs. Therefore, the burden of laborious and time-consuming aggressive periprocedural hydration to further reduce the risk of post-ERCP pancreatitis is not justified., Funding: Netherlands Organisation for Health Research and Development and Radboud University Medical Center., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Physical activity may affect disease activity in patients with inflammatory bowel disease. We used a survey to investigate this association and performed interviews to get a better understanding of patient experiences, and therefore the nature of this association., Methods: Patients with Crohn's disease (CD, n = 176) and ulcerative colitis (UC, n = 162) completed the short Crohn's Disease Activity (sCDAI) or Patient Simple Clinical Colitis Activity Index (P-SCCAI) and the Short Questionnaire to Assess Health-enhancing physical activity (SQUASH). Associations were investigated by multiple linear regression. Semi-structured interviews (7 CD, 7 UC) were conducted to assess patient experiences with the role of physical activity in their disease., Results: The majority of survey participants were in remission (70%) and adhered to the Dutch physical activity guidelines (61%). In Crohn's disease, the total physical activity score was inversely associated with disease activity, even after adjustment for confounders (β = - 0.375; p = 0.013). No association between physical activity and disease activity was found in ulcerative colitis. Of the interviewees, 86% experienced beneficial effects of physical activity, such as improved general fitness, quality of life and self-image. However, during periods of active disease they struggled to find the motivation and perseverance to be physically active due to physical barriers., Conclusions: Crohn's disease participants with a higher physical activity level had a lower disease activity. This inverse association was not found in ulcerative colitis. Interviews revealed that IBD patients generally experience beneficial effects from physical activity, although the barriers caused by active disease may put them off to be physically active.

Background and Objectives: The role of exercise in the management of inflammatory bowel disease (IBD) is inconclusive as most research focused on short or low-intensity exercise bouts and subjective outcomes. We assessed the effects of repeated prolonged moderate-intensity exercise on objective inflammatory markers in IBD patients., Methods: In this study, IBD patients (IBD walkers, n  = 18), and a control group (non-IBD walkers, n  = 19), completed a 30, 40 or 50 km walking exercise on four consecutive days. Blood samples were taken at baseline and every day post-exercise to test for the effect of disease on exercise-induced changes in cytokine concentrations. A second control group of IBD patients who did not take part in the exercise, IBD non-walkers ( n  = 19), was used to test for the effect of exercise on faecal calprotectin. Both IBD groups also completed a clinical disease activity questionnaire., Results: Changes in cytokine concentrations were similar for IBD walkers and non-IBD walkers (IL-6 p  = .95; IL-8 p  = .07; IL-10 p  = .40; IL-1β p  = .28; TNF-α p  = .45), with a temporary significant increase in IL-6 ( p  < .001) and IL-10 ( p  = .006) from baseline to post-exercise day 1. Faecal calprotectin was not affected by exercise ( p  = .48). Clinical disease activity did not change in the IBD walkers with ulcerative colitis ( p  = .92), but did increase in the IBD walkers with Crohn's disease ( p  = .024)., Conclusion: Repeated prolonged moderate-intensity walking exercise led to similar cytokine responses in participants with or without IBD, and it did not affect faecal calprotectin concentrations, suggesting that IBD patients can safely perform this type of exercise.

Background: Diet may play a role in disease status in patients with inflammatory bowel disease. We tested whether the inflammatory potential of diet, based on a summation of pro- and anti-inflammatory nutrients, is associated with disease activity in patients with Crohn's disease and ulcerative colitis., Methods: Participants completed a disease activity questionnaire (short Crohn's Disease Activity (sCDAI) or Patient Simple Clinical Colitis Activity Index (P-SCCAI)) and a Food Frequency Questionnaire (FFQ). FFQ data were used to calculate the Dietary Inflammatory Index (DII) which enables categorization of individuals' diets according to their inflammatory potential on a continuum from pro- to anti-inflammatory. Associations with disease activity were investigated by multiple linear regression., Results: The analysis included 329 participants; 168 with Crohn's disease (median sCDAI score 93 [IQR 47-156]), and 161 with ulcerative colitis (median P-SCCAI score 1 [IQR 1-3]). Mean DII was 0.71 ± 1.33, suggesting a slightly pro-inflammatory diet. In Crohn's disease, the DII was positively associated with disease activity, even after adjustment for confounders (p = 0.008). The mean DII was significantly different between participants in remission and with mild and moderately active disease (0.64, 0.97 and 1.52 respectively, p = 0.027). In ulcerative colitis, the association was not significant., Conclusions: Disease activity was higher in IBD participants with a more pro-inflammatory diet with statistical significance in Crohn's disease. Although the direction of causality is not clear, this association strengthens the role for diet in medical treatment, which should be tested in an intervention study.

Background & Aims: To improve the nutritional status of surgical patients before hospital admission, an Outpatient Nursing Nutritional Intervention (ONNI) was developed. The ONNI comprehends five components: determining causes of undernutrition, performing a nutritional care plan including tailored and general advice, self-monitoring of nutritional intake and eating patterns, counselling and encouragement, and conducting a follow-up telephone call to discuss improvements in nutritional behaviour. Here, we evaluate the feasibility and effectiveness of the ONNI., Methods: In a multi-centred, cluster-randomised pilot study, nurses from outpatient clinics were randomly allocated to usual care (UC) or the ONNI. Patients planned for elective surgery were included if they were at increased risk for undernutrition based on the Malnutrition Universal Screening Tool (MUST) and hospital admission was not planned within seven days. Feasibility outcomes included participation rate, extent of intervention delivery, and patient satisfaction. Nutritional intake was monitored for two days before admission. Body weight, BMI and MUST scores at hospital admission were compared to measurements from the outpatient clinic visit. Data were analysed on an intention-to-treat basis by researchers who were blinded for patients and caregivers., Results: Forty-eight patients enrolled the feasibility phase. Participation rate was 72%. Nurses delivered all intervention components adequately in the end of the implementation period. Finally, 152 patients (IG: n = 66, 43%) participated in the study. A significant difference in mean energy intake (870 kcal/d, 95%CI:630-1109 p < 0.000) and mean protein intake (34.1 g/d, 95%CI: 25.0-43.2; p < 0.000) was observed in favour of the IG. Nutritional energy requirements were achieved in 74% (n = 46) of the IG and in 17% (n = 13) of the UC group (p < 0.000), and protein requirements were achieved in 52% (n = 32) of the IG, compared to 8% (n = 6) of the UC group (p < 0.000). Body weight, BMI and MUST scores did not change in either group., Conclusions: The ONNI is a feasible and effective intervention tool for nurses at outpatient clinics. Patients in the IG had more nutritional intake and fulfilled nutritional requirements significantly more often than patients receiving UC. Further research is required to determine the optimal pre-operative timing of nutritional support and to measure its effect on other patients groups., Clinical Trial Registration: The study protocol was registered at the ClinicalTrial.gov website with the following identifier: NCT02440165., (Copyright © 2019 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Aims and Objectives: To analyse oral care delivery in one hospital through exploring experiences from both nurses' and patients' perspectives and examining patients' oral health., Background: Oral health problems are associated with undernutrition and other general health outcomes. Although oral care belongs to the essentials of nursing, it is often neglected. Improving oral health may require behaviour change of both nurses and patients. Defining tailored strategies need a clear view on the context., Design: A context analysis in one hospital using a convergent parallel mixed-methods design was reported following the EQUATOR guidelines using two checklists: COnsolidated criteria for REporting Qualitative research (qualitative research) and STROBE (observational research)., Methods: Semi-structured interviews were conducted with 19 nurses and 11 patients. The topic list was based on the Integrated Change Model. Prospective oral examination was performed among 91 surgical patients using the Oral Health Assessment Tool (OHAT)., Results: Nurses acknowledged that they did not prioritise oral care in daily practice. Furthermore, they lacked knowledge and skills to identify and provide care for oral problems. Nurses mentioned helpful resources to perform oral care, like standardised language and instruments. However, they had no access to or were unaware of them. Patients admitted that they did not prioritise oral care due to their sickness during hospitalisation, were unaware of the importance of oral care, but felt responsible for their oral care. The most prominent oral problems identified with the OHAT were unclean mouths (n = 75, 82%), unhealthy gum and tissues (n = 55, 60%) and dry mouth (n = 42, 46%)., Conclusions: This context analysis identified inadequate oral care due to lack of positive attitude and knowledge in both nurses and patients, skills for nurses, and resources., Relevance to Clinical Practice: The behavioural factors indicate strategies for development of a multicomponent intervention to improve oral care in this hospital, nutritional status and general health outcomes., (© 2019 John Wiley & Sons Ltd.)

Background & Aims: Peppermint oil is frequently used to treat irritable bowel syndrome (IBS), despite a lack of evidence for efficacy from high-quality controlled trials. We studied the efficacy and safety of small-intestinal-release peppermint oil in patients with IBS and explored the effects of targeted ileocolonic-release peppermint oil., Methods: We performed a double-blind trial of 190 patients with IBS (according to Rome IV criteria) at 4 hospitals in The Netherlands from August 2016 through March 2018; 189 patients were included in the intent-to-treat analysis (mean age, 34.0 years; 77.8% female; 57.7% in primary care), and 178 completed the study. Patients were randomly assigned to groups given 182 mg small-intestinal-release peppermint oil, 182 mg ileocolonic-release peppermint oil, or placebo for 8 weeks. The primary endpoint was abdominal pain response, as defined by the US Food and Drug Administration: at least a 30% decrease in the weekly average of worst daily abdominal pain compared with baseline in at least 4 weeks. The co-primary endpoint was overall relief of IBS symptoms, as defined by the European Medicines Agency. Secondary endpoints included abdominal pain, discomfort, symptom severity, and adverse events., Results: Abdominal pain response did not differ significantly between the peppermint oil and placebo groups: 29 of 62 patients in the small-intestinal-release peppermint oil group had a response (46.8%, P = .170 vs placebo), 26 of 63 patients in the ileocolonic-release peppermint oil group had a response (41.3%, P = .385 vs placebo), and 22 of 64 patients in the placebo group had a response (34.4%). We did not find differences among the groups in overall relief (9.7%, P = .317 and 1.6%, P = .351 vs 4.7% for placebo). The small intestinal peppermint oil did, however, produce greater improvements than placebo in secondary outcomes of abdominal pain (P = .016), discomfort (P = .020), and IBS severity (P = .020). Adverse events, although mild, were more common in both peppermint oil groups (P < .005)., Conclusions: In a randomized trial of patients with IBS, we found that neither small-intestinal-release nor ileocolonic-release peppermint oil (8 weeks) produced statistically significant reductions in abdominal pain response or overall symptom relief, when using US Food and Drug Administration/European Medicines Agency recommended endpoints. The small-intestinal-release peppermint oil did, however, significantly reduce abdominal pain, discomfort, and IBS severity. These findings do not support further development of ileocolonic-release peppermint oil for treatment of IBS. Clinicaltrials.gov, Number: NCT02716285., (Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Individuals with inflammatory bowel disease (IBD) often hold strong beliefs on how diet impacts their disease. This study aimed to compare dietary intakes between IBD patients and individuals from the general population and to assess associations of dietary factors with relapse in patients with IBD., Methods: Patients with longstanding Crohn's disease and ulcerative colitis (n = 165) filled out food frequency questionnaires, as did individuals participating in a Dutch population-based study (controls) (n = 1469). Multivariable regression analyses were used to assess differences in habitual dietary intake between IBD patients and controls, and to estimate associations of dietary factors in patients in remission with the development of disease relapse at follow-up., Results: IBD patients had higher intakes of animal protein (3.50 g/d, 95% confidence interval (CI) 1.67-5.34) and carbohydrate (10.1 g/d, 95% CI 5.23-14.9) than controls and lower intakes of (unsaturated) fat (-3.53 g/d, 95% CI -5.57- -1.50), dietary fiber (-2.19 g/d, 95% CI -3.05- -1.32) and alcohol (-0.84 g/d, 95% CI -1.46- -0.22). This was explained by a higher consumption of carbonated beverages, meat and poultry and lower consumption of fruit, vegetables and dairy products (except cheese) by IBD patients compared with controls. Several dietary factors, particularly (saturated) fat and fiber, appeared to be associated with risk of relapse., Conclusions: IBD patients had higher dietary intakes of (animal) protein and carbohydrate and lower intakes of (unsaturated) fat, dietary fiber and alcohol compared with a general Dutch population. The results further underscore that dietary factors may have a role in disease course., (Copyright © 2018 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Background and Aims: Ulcerative colitis (UC) is associated with an increased intestinal permeability, possibly through a dysbiosis of intestinal bacteria. We investigated which markers are most relevant to assess intestinal permeability in UC patients and whether probiotics had an effect on these markers., Methods: In this twelve-week placebo-controlled randomized double-blind study, twenty-five subjects with UC in remission received either placebo or a multispecies probiotics. Samples of blood, urine, and faeces were taken at baseline, week 6, and week 12 to assess intestinal permeability and inflammation. Diaries and Bristol stool scale were kept to record stool frequency and consistency. Quality of life was scored from 32-224 with the inflammatory bowel disease questionnaire (IBD-Q)., Results: This group of UC patients, in clinical remission, did not show increased intestinal permeability at baseline of this study. During the study, no significant group or time effects were found for intestinal permeability measured by the 5-sugar absorption test, serum zonulin, and faecal zonulin. Likewise, the inflammatory markers C-reactive protein (CRP), calprotectin, and the cytokines IFN γ , TNF α , IL-6, and IL-10 were not significantly affected. Stool frequency and consistency were not significantly affected either. The IBD-Q score, 194 for the probiotics group and 195 for the placebo group, remained unaffected. Correlations were tested between all outcomes; urinary sucrose excretion was significantly correlated with serum zonulin ( r  = 0.62) and faecal calprotectin ( r  = 0.55). Faecal zonulin was not significantly correlated with any of the other markers., Conclusion: Serum zonulin may be a more relevant biomarker of intestinal permeability than faecal zonulin, due to its correlation with other biomarkers of intestinal permeability. UC patients in remission did not show an effect of the probiotic treatment or a change in gut permeability. This should not discourage further studies because effects might be present during active disease or shortly after a flare up.

Background: The inflammatory bowel disease (IBD) is a chronic lifelong inflammation that may affect the entire gastro-intestinal tract in Crohn's disease and the colon in ulcerative colitis (UC). Diet plays an important role in IBD patients and many of them follow strict diet restriction in order to reduce complaints and prolong remission intervals. The aim of this study was to assess dietary beliefs, dietary behaviour and nutrition knowledge in Dutch adults with IBD to enable considering the patient's perspective on dietary advice., Methods: A self-administered online questionnaire assessing general characteristics, dietary beliefs and behaviour, nutrition knowledge and sources and dietary advice was devised. The questionnaire was distributed to members of the Dutch Crohn and UC patient association of whom 294 participated in the study., Results: Fifty-nine per cent of the patients valued nutrition to be either more or equally important compared to medication for their treatment and 62% believed diet to be more important in influencing the disease course. Sixty-two per cent reported to be successful in controlling disease symptoms through dietary adaptations. Avoiding certain foods was preferred over eating more beneficial foods or following specific diets (77 vs. 57% and 48% respectively). Dietary supplements were used by 68% of the IBD patients. Although over 71% had received dietary advice mainly by dieticians, 81% stated that the main source of their nutritional knowledge related to IBD was their own experience., Conclusion: A subgroup of IBD patients considered diet to be a more important and successful managing tool than medication to relieve their disease symptoms., (© 2018 The Author(s) Published by S. Karger AG, Basel.)

Background: Indirect methods to assess gastric emptying (GE), such as 13 C breath tests (BT), are commonly used. However, BT usually use a sampling time of 4+ hours. The current study aims to assess the validity of BT for four liquid meals differing in physicochemical properties. To this aim, we compared them to MRI GE-measurements., Methods: Fifteen healthy males (age 22.6 ± 2.4 years, BMI 22.6 ± 1.8 kg/m 2 ) participated in a randomized 2 × 2 crossover experiment. Test foods were liquid meals, which were either thin/thick and 100/500 kcal, labeled with 100 mg of 13 C-octanoate. GE was measured with MRI and assessed by 13 C recovery from breath. Participants were scanned every 10 minutes and at six time points breath samples were collected up to t = 90 minutes. Two curves were fitted to the data to estimate emptying halftime (t 50 Ghoos and t 50 Bluck ). T 50 times were ranked per participant and compared between methods., Key Results: On average, MRI and BT showed similar t 50 rankings for the four liquid meals. In comparison to MRI, t 50 Ghoos overestimated, while t 50 Bluck underestimated GE time . Moreover, more viscous foods were overestimated. In most participants individual t 50 time rankings differed significantly between methods., Conclusions & Inferences: BT can assess relative emptying differences on group level and collecting breath data for 90 minutes constitutes a lower burden for participants and the research facility. However, BT has severe shortcomings compared to MRI for individual GE assessment. Notably, food matrix effects should be considered when interpreting the results of BT., (© 2018 The Authors. Neurogastroenterology & Motility Published by John Wiley & Sons Ltd.)

Background: A low vitamin D status has been put forward as a potential risk factor for the development of inflammatory bowel disease (IBD). This study investigated the association between prediagnostic circulating vitamin D concentrations and dietary intakes of vitamin D, and the risk of Crohn's disease (CD) and ulcerative colitis (UC)., Methods: Among 359,728 participants of the European Prospective Investigation into Cancer and Nutrition cohort, individuals who developed CD or UC after enrollment were identified. Each case was matched with2 controls by center, gender, age, date of recruitment, and follow-up time. At cohort entry, blood samples were collected and dietary vitamin D intakes were obtained from validated food frequency questionnaires. Serum 25-hydroxyvitamin D levels were measured using liquid chromatography-tandem mass spectrometry. Conditional logistic regression was performed to determine the odds of CD and UC., Results: Seventy-two participants developed CD and 169 participants developed UC after a median follow-up of 4.7 and 4.1 years, respectively. Compared with the lowest quartile, no associations with the 3 higher quartiles of vitamin D concentrations were observed for CD (p trend = 0.34) or UC (p trend = 0.66). Similarly, no associations were detected when serum vitamin D levels were analyzed as a continuous variable. Dietary vitamin D intakes were not associated with CD (p trend = 0.39) or UC (p trend = 0.83)., Conclusions: Vitamin D status was not associated with the development of CD or UC. This does not suggest a major role for vitamin D deficiency in the etiology of IBD, although larger studies are needed to confirm these findings.

Objective: In non-conventional care, high doses of vitamin B 12 supplementation are used for the treatment of fatigue even in case of normal vitamin B 12 blood levels. We performed a randomized placebo controlled trial to investigate the effect of surplus oral vitamin B 12 supplementation on fatigue in patients with IBS or IBD., Methods: This randomized double-blind, placebo-controlled trial included 95 out-clinic IBS and IBD patients with deactivating fatigue and normal vitamin B 12 blood levels (≥150 pmol/l) aged 18-65 years. Participants were randomly assigned to receive 1000 μg vitamin B 12 daily or a placebo supplement for 8 weeks. The primary outcome measure was fatigue (Checklist Individual Strength (CIS)). In addition, measures of quality of life and depression were examined., Results: No significant difference in scores of the CIS subscale 'subjective fatigue' was observed between the intervention group and the control group with changes in scores of -8.1 ± 9.5 and -8.3 ± 10.6 (95% CI -11.65 to 6.71), respectively. The scores on the CIS subscale 'motivation' improved with a significant change in scores of -2.2 ± 4.6 (95% CI -4.4 to -0.04). No significantly increased scores were observed for depression or quality of life in the intervention group compared to the control group., Conclusion: This study did not confirm the expected effect of non-conventional surplus vit B 12 supplementation on fatigue in IBS or IBD patients. In addition, no positive effect was observed on depression or quality of life. We conclude that surplus treatment with vitamin B 12 in IBS and IBD patients suffering from fatigue has no beneficial clinical effect., (Copyright © 2017 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.)

Objectives: Sufficient protein intake and habitual physical activity are key factors in the prevention and treatment of sarcopenia. In the present study, we assessed habitual dietary protein intake and the contribution of animal proteins in male versus female physically active elderly and identified determinants of protein intake., Design: a cross-sectional study., Setting: the study was performed within the Nijmegen Exercise Study., Participants: physically active elderly ≥ 65 yrs., Measurements: Physical activity was assessed using the SQUASH questionnaire and expressed in Metabolic Equivalent of Task hours per week (METhr/wk). Dietary protein intake was determined using a validated food frequency questionnaire (FFQ). Multivariate linear regression analysis was used to determine whether age, sex, educational level, smoking, alcohol intake and physical activity were associated with protein intake (g/kg/d)., Results: A total of 910 participants (70±4 yrs, 70% male) were included and reported a habitual physical activity level of 85.0±53.5 METhr/wk. Protein intake was 1.1±0.3 g/kg/d with 57% animal-based proteins for males, and 1.2±0.3 g/kg/d with 59% animalbased proteins for females (both P<0.05). In total, 16%, 42% and 67% of the male elderly and 10%, 34% and 56% of the female elderly did not meet the recommended protein intake of 0.8, 1.0 and 1.2 g/kg/d, respectively. Female sex (β=0.055, P=0.036) and more physical activity (β=0.001, P=0.001) were associated with a higher daily protein intake (g/kg/d)., Conclusion: The majority of physically active elderly and in particular males (i.e. 67%) does not reach a protein intake of 1.2 g/kg/d, which may offset the health benefits of an active lifestyle on muscle synthesis and prevention of sarcopenia. Intervention studies are warranted to assess whether protein supplementation may enhance muscle mass and strength in physically active elderly., Competing Interests: The authors do not have any conflicts of interest to declare.

Background/objectives: Migraine, associated with several gastrointestinal disorders, may result from increased intestinal permeability, allowing endotoxins to enter the bloodstream. We tested whether probiotics could reduce migraine through an effect on intestinal permeability and inflammation., Subjects/methods: In total, 63 patients were randomly allocated to the probiotic (n=31) or the placebo group (n=32). Participants ingested a multispecies probiotic (5x10 9 colony-forming units) or placebo daily for 12 weeks. Migraine was assessed with the Migraine Disability Assessment Scale (MIDAS), the Headache Disability Inventory (HDI) and headache diaries. At baseline and 12 weeks, intestinal permeability was measured with the urinary lactulose/mannitol test and fecal and serum zonulin; inflammation was measured from interleukin (IL) -6, IL-10, tumor necrosis factor-α and C-reactive protein in serum., Results: The MIDAS migraine intensity score significantly decreased in both groups (P<0.001) and the HDI score significantly decreased in the probiotic group (P=0.032) and borderline in the placebo group (P=0.053). In the probiotics group, patients had a median of 6 migraine days in the first month, 4 in the second month (P=0.002) and 5 in the last month, which was not significantly different from the 5, 4, and 4 days in the placebo group. A ⩾2day reduction in migraine days was seen in 12/31 patients in the probiotics group versus 7/29 in the placebo group (ns). Probiotic use did not significantly affect medication use, intestinal permeability or inflammation compared to placebo., Conclusions: In this study, we could not confirm significant benefit from a multispecies probiotic compared to a placebo on the outcome parameters of migraine and intestinal integrity.

Objective: To validate published diagnostic models for their ability to safely reduce unnecessary endoscopy referrals in primary care patients suspected of significant colorectal disease., Study Design and Setting: Following a systematic literature search, we independently validated the identified diagnostic models in a cross-sectional study of 810 Dutch primary care patients with persistent lower abdominal complaints referred for endoscopy. We estimated diagnostic accuracy measures for colorectal cancer (N = 37) and significant colorectal disease (N = 141; including colorectal cancer, inflammatory bowel disease, diverticulitis, or >1-cm adenomas)., Results: We evaluated 18 models-12 specific for colorectal cancer-, of which most were able to safely rule out colorectal cancer: the best model (National Institute for Health and Care Excellence-1) prevented 59% of referrals (95% confidence interval [CI]: 56-63%), with 96% sensitivity (95% CI: 83-100%), 100% negative predictive value (NPV; 95% CI: 99-100%), and an area under the receiver operating characteristics curve (AUC) of 0.86 (95% CI: 0.80-0.92). The models performed less for significant colorectal disease: the best model (Brazer) prevented 23% of referrals (95% CI: 20-26%), with 95% sensitivity (95% CI: 90-98%), 96% NPV (95% CI: 92-98%), and an AUC of 0.73 (95% CI: 0.69-0.78)., Conclusion: Most models safely excluded colorectal cancer in many primary care patients with lower gastrointestinal complaints referred for endoscopy. Models performed less well for significant colorectal disease., (Copyright © 2016 Elsevier Inc. All rights reserved.)