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Scarce data are available on the use of vedolizumab in children with inflammatory bowel disease (IBD). We aimed to evaluate the safety, effectiveness, and dosing of vedolizumab to induce remission of IBD.VEDOKIDS was a paediatric, multicentre, prospective cohort study done in 17 centres in six countries. We report the 14-week outcomes as the first analyses of the planned 3-year follow-up of the VEDOKIDS cohort. Children (aged 0-18 years) with IBD who had commenced vedolizumab were followed up at baseline and at 2, 6, and 14 weeks. Children were managed according to local prescribing practices without standardisation of dosing or criteria for escalation, but the study protocol suggested dosing of 177 mg/mBetween May 19, 2016, and April 1, 2022, 142 children (76 [54%] girls and 66 [46%] boys; mean age 13·6 years [SD 3·6]) were enrolled. 65 (46%) children had Crohn's disease, 68 (48%) had ulcerative colitis, and nine (6%) had unclassified IBD (those with unclassified IBD were analysed with the ulcerative colitis group). 32 (42% [95% CI 30-54]) of 77 children with ulcerative colitis and 21 (32% [23-45]) of 65 children with Crohn's disease were in steroid-free and exclusive enteral nutrition-free remission at 14 weeks. Median drug concentrations at week 14 were higher in children with ulcerative colitis than in those with Crohn's disease (11·5 μg/mL [IQR 5·5-18·1] vs 5·9 μg/mL [3·0-12·7]; p=0·006). In children who weighed less than 30 kg, the optimal drug concentration associated with steroid-free and exclusive enteral nutrition-free clinical remission was 7 μg/mL at week 14 (area under the curve 0·69 [95% CI 0·41-0·98]), corresponding to a dose of 200 mg/mVedolizumab showed good safety and effectiveness at inducing remission in children with IBD at 14 weeks, especially those with ulcerative colitis. Vedolizumab should be considered in children when other approved drug interventions for IBD are unsuccessful. In children who weigh less than 30 kg, vedolizumab should be dosed by the child's body surface area (200 mg/mThe European Crohn's and Colitis Organization, the European Society for Paediatric Gastroenterology Hepatology and Nutrition, and Takeda.

One of the main causes of iron deficiency anemia (IDA) is chronic gastrointestinal blood loss. The use of video capsule endoscopy (VCE) after negative bidirectional endoscopy in patients with IDA is controversial.To evaluate the effect of VCE in the management and long-term outcomes of IDA patients.A retrospective case-control study was performed on all patients with IDA undergoing VCE over a 5-year period. We compared those with positive findings on VCE to those with normal findings. All participants previously underwent a negative bidirectional endoscopy.We performed 199 VCE examinations; median follow-up time was 4 years (IQR 2-5). Positive findings were identified in 66 patients (diagnostic yield 33.2%). Double balloon enteroscopy or push enteroscopy was performed in eight patients (18.6%); only one was therapeutic. The main therapy in both groups was iron supplementation. There were no significant differences in iron treatment before and after VCE in each group and between groups. Anemia improved in both groups. There was no difference in the level of hemoglobin change between the groups during each year of follow-up compared to the baseline level prior to VCE. Anemia resolved in 15 patients (35%) in the positive VCE group and in 19 (45%) in the negative VCE group (P = 0.33).Positive findings on VCE led to subsequent endoscopic interventions only in a small percentage of patients with IDA. Anemia improved and resolved equally whether or not there were VCE findings. The main intervention that appears to help IDA is iron supplementation.

Background Direct-acting antiviral (DAA) regimens and telemedicine services are both options for treating hepatitis C virus (HCV) within the prison setting. We aimed to compare factors associated with HCV treatment success over the past decade in Israeli prisons, specifically the influence of DAAs and telemedicine. Methods We retrospectively reviewed the medical records of inmates with HCV infection in Israeli prisons from 2010 through 2020. Demographic, clinical, and laboratory data were recorded, including treatment regimens and success rates. Results A total of 273 inmates were treated; mean age 45 ± 9.36 years; 98.2% males; 63.9% with a history of drug abuse. Advanced fibrosis was documented in 42.9%. The most common genotypes were 1 (46%) followed by 3 (40.7%). Interferon-based regimens were given to 68 inmates between 2010 and 2017. DAA agents were introduced in 2016, with pan-genotype regimens being exclusively used since 2019. Telemedicine services were used in 140 patients (51.3%), starting in February 2019. The sustained viral response (SVR) rate with interferon-based therapy was 78.8% and 98.8% with DAA treatment, giving an overall SVR of 93.2%. This difference between regimens proved to be the only statistically significant predictor of treatment success. The number of prisoners being treated with DAAs increased exponentially after telemedicine was introduced. Comparable SVR rates were achieved with either in-person or telemedicine consultation. Conclusion Screening of this high-risk population and using telemedicine for treatment may be an effective strategy for the elimination of HCV from the prison population.

Caustic ingestion in children is a significant cause of morbidity despite preventive measures. Upon arrival to the emergency department, these children are often initially seen by the otolaryngologist and later on by the gastroenterologist. This study aimed to determine which otolaryngological and gastrointestinal signs and symptoms can better predict abnormal findings on imaging, esophagogastroduodenoscopy (EGD), and complications development.We performed a retrospective chart review of children 18 years or younger admitted because of caustic ingestion between January 2007 and November 2019.Forty-one children with a median age of 4.2 years (interquartile range, 1.7-16.7 years) were included; of them, 22 (53.6%) were males. Nineteen children (46.3%) underwent EGD, which revealed no pathology in 13 cases (68.4%). Most ingested substances were in the form of liquid (82.9%), accidentally ingested (82.9%), and with an alkaline pH (57.5%). Stridor, dyspnea, drooling, abnormal oral cavity findings, dysphagia, and vomiting were significantly associated with pathological findings on imaging and/or EGD and/or complications development ( P = 0.028, P = 0.028, P = 0.022, P = 0.02, P0.001, and P = 0.01 respectively). Laryngopharyngeal group of findings (dyspnea, stridor, hoarseness, sore throat, and/or drooling) predicted a higher risk for complications development than the gastrointestinal group (dysphagia, abdominal pain, vomiting, or abdominal swelling and/or tenderness) ( P = 0.011, P = 0.31 respectively).In children, after caustics ingestion, laryngopharyngeal signs and symptoms may predict a higher risk for complications development in comparison with gastrointestinal signs and symptoms. We therefore stress the importance of otolaryngological examination upon arrival to the emergency department.

Fewer than 40 cases of achalasia occurring in pregnant woman have been reported in the literature. Given the rarity of achalasia during pregnancy, and the numerous treatment options that are available for achalasia in general, no guidelines exist for the management of achalasia during pregnancy. Diagnosis of new cases may be difficult as symptoms and physiological changes that occur during pregnancy may obscure the clinical presentation of achalasia. The management of achalasia in pregnancy is also challenging. Treatment decisions should be individualized for each case, considering both the welfare of the mother and the fetus. Since pregnant women suffering from achalasia represent a diagnostic and therapeutic challenge with complex maternal-fetal aspects to consider, we have reviewed the available literature on the subject and summarized current diagnostic and therapeutic options. Additionally, we present a management algorithm as a means to guide treatment of future cases. We recommend that a conservative approach should be adopted with bridging therapies performed until after delivery when definitive treatment of achalasia can be more safely performed. (J Neurogastroenterol Motil 2021;27:8-18)

IntroductionAnxiety and depression are common disturbances in patients with inflammatory bowel diseases (IBD), and were found to impact the disease course. Illness perceptions (IPs), self-efficacy (SE) and sense of coherence (SOC) are important psychological functions, used by the individual to cope with his chronic disease.Aimsto investigate the association of IP, SE and SOC on anxiety and depression among patients with IBD.Patients and methodsPatients filled questionnaires including: demographic, socioeconomic and clinical features. Depression and anxiety were assessed using the Hospital Anxiety and Depression Scale. IP, SE and SOC were assessed using the Brief Illness perception Questionnaire, IBD-SE and SOC scales.ResultsThe study sample consisted of 299 patients with IBD, median age 34.15, 63% females, 70.9% had Crohn’s disease, filled the questionnaires. In the multivariate analysis, lower results in IP, SE and SOC were found to be associated with significantly increase anxiety (OR 8.35, pConclusionsAnxiety and depression are associated with IP, SE and SOC in patients with IBD. Clinicians should be aware of this impact, recognise their patients’ psychological abilities to cope with the disease and improve those abilities, when needed, in order to achieve a better coping with the disease and to prevent the development of anxiety and depression.

Objective Different infectious agents have been presumed to be candidates acting as an etiologic factor or trigger of Crohn's disease (CD). Group A Streptococcus (GAS) is a common human infection agent that can also trigger post-infectious immune-mediated conditions. The current study aimed to examine whether the immunogenic activity induced by GAS may trigger new-onset of CD. Methods Data for antistreptolysin O (ASO) level, throat culture for GAS, and history of streptococcal infection were collected from 91 patients with CD that were divided into three groups including; new-onset CD, CD in remission and active CD. The data were compared with the control group. Results All participants had negative results of throat culture for GAS and had no history of documented streptococcal infection in the past year. Our results indicate that new-onset CD, but not CD in remission or active CD, is associated with significantly increased positive ASO compared to controls. Half of the patients in the new-onset CD group were ASO positive, which was significantly higher compared to the control group in a univariant (OR: 4.00; 95% CI 1.27-12.58; P=0.02) and multivariant analysis (OR: 4.41; 95% CI 1.35-14.37; P=0.014). Conclusion Our study is the first to focus on ASO levels in patients with CD and to demonstrate a significant association between ASO and new-onset of CD. Large prospective randomized controlled studies are needed to confirm the validity of this data and to further clarify the clinical significance of our findings.

Inflammatory bowel disease (IBD) patients' expectations of treatment outcomes may differ by ethnicity.To investigate treatment preferences of Jewish and Arabs patients.This prospective survey ranked outcomes treatment preferences among Arab IBD patients, based on the 10 IBD-disk items compared to historical data of Jews. An anonymous questionnaire in either Arabic or Hebrew was distributed among IBD patients. Patients were required to rank 10 statements describing different aspects of IBD according to their importance to the patients as treatment goals. Answers were compared to the answers of a historical group of Jewish patients.IBD-disk items of 121 Arabs were compared to 240 Jewish patients. The Jewish patients included more females, [151 (62.9%)The highest priority for treatment outcomes was symptom relief., Patients preferences were impacted by ethnicity, gender, and socio-economic disparity. Understanding patients' priorities may improve communication and enable a personalized approach.

BACKGROUND: The association of Helicobacter pylori-negative gastritis with lymphoid follicles (LFs) in children is still unclear. Therefore, we aimed to investigate the natural history and significance of H. pylori-negative gastritis with LFs in children. METHODS: We identified children with histologically proven H. pylori-negative gastritis with LFs between June 2014 and January 2017. The children were invited for a follow-up examination. The clinical, endoscopic, and histological findings of the index esophagogastroduodenoscopy (EGD) were revised and compared to the follow-up findings. RESULTS: A total of 754 children underwent EGD. Among the 48 children diagnosed with H. pylori-negative gastritis, 17 (35.41%) had gastric LFs. Eight agreed to participate in the study. The mean follow-up was 25.58 ± 4.52 (range, 20.53-35.73) months. Three children still had histologic findings of chronic gastritis with LFs. Four children had resolution of the gastritis but still had LFs, and 1 patient had resolution of both the gastritis and LFs. CONCLUSION: LFs were still present in children with H. pylori-negative gastritis after a mean follow-up of 2 years, and in some children, despite resolution of the gastritis. Therefore, this histological finding might be a non-pathological feature in children and does not need any contribution or follow-up.

OBJECTIVE Inflammatory bowel disease (IBD) significantly impacts on patients' well-being. Patients' preferences for treatment outcomes do not necessarily fit physicians' goals. We aimed to investigate patients' priorities and expectations from treatment. METHODS A questionnaire based on the IBD Disk application was distributed to patients through social media. Patient's preferences were assessed by grading the 10 IBD Disk items on a Likert-type scale from 1 to 10. A cluster analysis was used to classify patients into homogeneous subgroups according to their preferred items, using the K-means method. RESULTS Among the 224 patients, 69.2% had Crohn's disease (CD). Their mean age was (38.9 ± 14.9) years and 62.9% were female. More CD patients compared with those with ulcerative colitis were treated with biologics compared with those with ulcerative colitis (71.0% vs 39.1%, P < 0.001). Most IBD Disk items ranked high in patients' preferences for treatment outcomes. Their leading preference was reducing abdominal pain, which was more prominent in CD patients, followed by regulating defecation and energy. Least important were interpersonal interactions, sexual functions, and body image. Patients were categorized into three clusters. Cluster 3 patients gave lower scores to most items and were characterized by tertiary education (P = 0.001), higher income (P

Background Surgery is the preferred option for patients with symptomatic localized fibrostenotic ileocecal Crohn’s disease (CD) but not for those with predominantly active inflammation without obstruction. The benefit of early surgery in patients with a limited nonstricturing ileocecal CD over biologic treatment is still a debate. Objective Our objective is to formulate a decision analysis model based on recently published data to explore whether early surgery in patients with limited nonstricturing CD is preferred over biologic treatment. Methods We constructed a Markov model comparing 2 strategies of treatment: (1) early surgery vs (2) biologic treatment. To estimate the quality-adjusted life years (QALYs) and the costs in each strategy, we simulated 10,000 virtual patients with the Markov model using a Monte Carlo simulation 100 times. Sensitivity analyses were performed to evaluate the robustness of the model and address uncertainties in the estimation of model parameters. Results The costs were $29,457 ± $407 and $50,382 ± $525 (mean ± SD) for early surgery strategy and biologic treatment strategy, respectively. The QALY was 6.24 ± 0.01 and 5.81 ± 0.01 for early surgery strategy and biologic treatment strategy, respectively. Conclusion The strategy of early surgery dominates (higher QALY value [efficacy] and less cost) compared with the strategy of biologic treatment in patients with limited ileocecal CD.

Background The PAILOT trial was a randomized controlled trial aimed to evaluate proactive vs reactive therapeutic drug monitoring in children with Crohn’s disease (CD) treated with adalimumab. Our aim in this post hoc analysis of the PAILOT trial was to assess the efficacy and safety of adalimumab combination treatment in comparison with monotherapy at week 72 after adalimumab induction. Methods Participants were children 6–17 years old, biologic naïve, with moderate to severe CD, who responded to adalimumab induction at week 4. Patients receiving immunomodulators at baseline maintained a stable dose until week 24; patients could then discontinue immunomodulators. At each visit, patients were assessed for disease index, serum biomarkers, fecal calprotectin, adalimumab trough concentration, and anti-adalimumab antibodies. Results Out of the 78 patients (29% female; mean age, 14.3 ± 2.6 years), 34 patients (44%) received combination therapy. During the study period, there was no significant difference in the rates of sustained corticosteroid-free clinical remission (25/34, 73%, vs 28/44, 63%; P = 0.35) or sustained composite outcome of clinical remission, C-reactive protein ≤0.5 mg/dL, and calprotectin ≤150 µg/g (10/34, 29%, vs 14/44, 32%; P = 0.77) between the combination group and the monotherapy group, respectively. Clinical and biological outcomes did not differ between the proactive and reactive subgroups within the combination and monotherapy groups. Adalimumab trough concentrations and immunogenicity were not significantly different between groups. The rate of serious adverse events was not significantly different between groups but was numerically higher in the monotherapy group. Conclusions Combination therapy of adalimumab and an immunomodulator was not more effective than adalimumab monotherapy in children with CD (ClinicalTrials.gov No. NCT02256462).

Summary Objective Obesity is a major public health issue with significant impact on quality of life, morbidity and mortality rates. It is estimated that if the current trends continue, 18% of men and 21% of women worldwide will be obese by 2025. All the current therapies are not optimal due to limited efficacy or safety; thus, there is a need for additional devices for the treatment of obesity. This study aimed to examine the safety, tolerability, and efficacy of a biodegradable encapsulated Epitomee device for weight loss. The technology is based on absorbent pharmaceuticals polymers and bonding materials that self‐expand in the stomach to create a pH‐sensitive super absorbent gel structure for weight loss. Methods A prospective, 12‐week twice daily use of the encapsulated device in patients with body mass index of 27–40 kg m−2. Efficacy endpoints were the percent total body weight loss (%TBWL), proportion of participants with 5% TBWL and changes in cardio‐metabolic markers. Safety analysis included evaluation of adverse events, laboratory and endoscopic findings. Results Overall, 52 patients completed the study. TBWL per intension‐to‐treat analysis was 3.68 ± 3.07% (3.23 ± 2.69 kg) and 4.52 ± 2.97% (3.95 ± 2.57 kg) per protocol. No device serious adverse effects reported. The most common adverse events were headache (18.1%), viral infection (11.5%), abdominal discomfort (10.1%), bloating (7.9%), nausea and constipation (5% each) and flatulence (4.3%). Endoscopy in 26 patients revealed mild, asymptomatic gastric/duodenal erythema without erosions in five patients. Conclusions Twelve weeks of Epitomee capsules treatment combined with lifestyle counselling resulted in 3.68–4.52% of TBWL. With continued research, the Epitomee capsules have considerable potential to become a non‐invasive, safe and effective treatment option for weight loss.

OBJECTIVES: The coronavirus disease 2019 (COVID-19) pandemic raised concerns among inflammatory bowel disease (IBD) patients fearing an increased risk of infection and poor outcomes. We aimed to evaluate the incidence of COVID-19 among IBD patients; its influence on disease severity and outcome; its relationship to medication use and how the pandemic affected IBD management. METHODS: An anonymous questionnaire was posted online to members of the Israel Crohn's Disease and Ulcerative Colitis Foundation (November 2020-January 2021). The questionnaire addressed the course of IBD disease and COVID-19 infection over the past year. RESULTS: Total 2152 IBD patients completed the questionnaire. Of which 104 (4.8%) had been infected with COVID-19, significantly lower than the 'expected' infected cases among the Israeli population (P = 0.033). The median age of participants was 39 years; 60.5% were female. Most patients (75.6%) had no comorbidities other than IBD. No correlation was found between IBD type or disease severity and COVID-19 infection. Most IBD patients reported mild COVID-19 disease, regardless of the type of IBD medications. Multivariable logistic regression analysis revealed that younger age, elevated BMI and diabetes were independent risk factors for COVID-19 infection. IBD treatment methods including 5-aminosalicylic acid, smoking and hypertension were protective factors. In total 25.2% of COVID-19 patients discontinued their IBD treatment, compared to 8.5% of non-COVID-19-infected patients. IBD flares were significantly higher in those who discontinued treatment (P < 0.001). CONCLUSIONS: IBD patients do not have an increased risk for COVID-19, regardless of IBD activity or treatment. Patients should be encouraged to continue effective IBD therapy, including biologics and steroids, to minimize active IBD.

OBJECTIVES In this quality improvement program, named quality in pediatric inflammatory bowel disease, we constructed a nation-wide platform that prospectively recorded clinically important quality indicators in pediatric inflammatory bowel diseases (PIBD), aiming at improving clinical management across the country. METHODS Representatives of all 21 PIBD facilities in Israel formed a Delphi group to select quality indicators (process and outcomes), recorded prospectively over 2 years in children with Crohn's disease 2-18 years of age seen in the outpatient clinics. Monthly anonymized reports were distributed to all centers, allowing comparison and improvement. Trends were analyzed using the Mann-Kendall test, reporting τ (tau) values. RESULTS The indicators of 3254 visits from 1709 patients were recorded from September 2017 to September 2019 (mean age 14.7 ± 3.1 years, median disease duration 1.8 years (interquartile range 0.69-4.02)). An increase in three of five process indicators was demonstrated: obtaining drug levels of anti-tumor necrosis factor (TNF) (τ = 0.4; P = 0.005), utilization of fecal calprotectin (τ = 0.38; P = 0.008) and bone density testing (τ = 0.45; P = 0.002). Among outcome indicators, three of nine improved as measured during the preceding year: calprotectin

OBJECTIVES Growth impairment is common in children with Crohn disease (CD). We aimed to assess the effect of adalimumab (ADL) treatment on linear growth in children with CD in a post-hoc analysis of the Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment randomized controlled trial. METHODS Children 6 to 17 years who responded to ADL induction were assessed consecutively for anthropometric parameters. Associations of these parameters with disease characteristics and disease activity were analyzed. RESULTS Overall, 66 patients completed 72 weeks of follow-up (25% girls, mean age of 15.6 ± 2.5 years). Median (interquartile range [IQR]) height z score improved from -0.6 (-1.6-0.15) at baseline to -0.33 (-1.3-0.5) at week 72 (P = 0.005) with lesser improvement in patients with perianal disease. Similar effect was noted in children with growth potential (boys younger than 16 years, girls younger than 14 years). Median (IQR) height velocity standard deviation was -0.32 (-1.5-0.8) at week 26, and +0.11 (-1.1-1.3) at week 72. Median weight z score increased from -0.54 (-1.2-0.15) to -0.1 (-0.9-0.6), P

Objectives Small bowel involvement in Crohn disease (CD) is clinically important for diagnosis and treatment. Single and double-balloon enteroscopy have already become important diagnostic tools in such cases. The on-demand NaviAid AB device enables deep advancement into the small bowel, using an anterograde or retrograde approach. In adults, this procedure is feasible, safe, and rapid. This work aimed to assess the safety and feasibility of NaviAid AB enteroscopy in pediatric patients. Methods Single-center, prospective study using the through-the-scope balloon-assisted-enteroscopy (TTS-BAE) NaviAid AB device for the evaluation of the small bowel in children with suspected or known inflammatory bowel disease (IBD). The system consists of a single-use balloon catheter inserted through the instrument channel of a standard colonoscope. It consists of an inflation/deflation system (NaviAid SPARK), which is inflated to anchoring pressure. The repetitive push-pull technique enables the advancement of the colonoscope along the small intestine. Results Fifty analyzed endoscopic procedures (30 retrograde, 20 anterograde) were performed in 34 children (52.9% boys, mean age 13.7 years). Average maximal depth of insertion (MDI), advancement depth using the NaviAid AB and average total procedure time were 138 cm (range 100-190 cm), 81 cm (range 40-120 cm), and 12.8 minutes (range 7.3-19.0 minutes), respectively, for the anterograde approach and 143 cm (range 100-170 cm), 64 cm (range 20-95 cm), and 21.9 minutes (range 13.9-32.0 minutes), respectively, for the retrograde approach. No serious or device-related adverse events were reported. Conclusions NaviAid AB enteroscopy in children is safe, feasible, and enables assessment of the small intestine in a short period of time.

Background Adherence is generally associated with improved treatment outcomes in inflammatory bowel disease (IBD) patients. Different components of the patient profile have an impact on patient adherence. Capturing nonadherent patients by identifying modifiable risk factors in daily practice still remains a challenge. The objective of this study was to identify modifiable and nonmodifiable risk factors for nonadherence in IBD patients. Methods Patients filled out questionnaires including demographic, clinical, and socioeconomic information and accessibility to gastrointestinal services. Psychological features were assessed using the Sense of Coherence, Hospital Anxiety and Depression Scale, IBD-Self Efficacy, and Brief Illness Perception (BIPQ) questionnaires. Adherence to treatment was evaluated using the Morisky score. Results The study included 311 patients: 62.4% females, median age 34.78 years, 70.4% Crohn's disease (CD). Multivariate analysis was done in 3 sections: demographic and disease characteristics, communication with medical staff, and psychological aspects; all included sex and disease type. Ulcerative colitis (UC) patients were less adherent (odds ratio [OR], 1.792; OR, 1.915; OR, 1.748; respectively). Females were less adherent in 2 sections (OR, 1.841; OR, 1.751; respectively). Employment (OR, 2.449), low score in on the BIPQ-understanding of disease (OR, 0.881), and poor communication with the gastroenterologist (OR, 1.798) were also predictors of low adherence. Conclusions Nonmodifiable characteristics such as female sex and UC are associated with low adherence. Good communication with the treating physician and understanding the disease are modifiable factors associated with high adherence. Early intervention might improve patients' adherence.

Background Biologic treatments are inherently associated with an increased risk of infections, and recipients are intuitively considered at-risk for a more severe course of COVID-19. However, the actual risks are not fully described, neither are the appropriate adjustments needed to mitigate such risks. Methods Nation-wide registry was set up by Israeli IBD Section, to characterize course of COVID-19 in IBD patients who contacted SARS-CoV-2 infection while on biologics. We prospectively collected demographic and clinical data, and analyzed COVID-19 outcomes with regard to the specific treatments. Results Between Apr and Oct 2020, 144 patients with an established IBD diagnosis and confirmed COVID-19 were enrolled at 20 IBD referral centers. The majority of patients was under the age of 40 (113, 78%), 9 (6%) were younger than 18, only 4 patients (3%) over the age of 70. 94 patients received biologics, as monotherapy (76, 52.8%), combined with immunomodulators (9, 10%) or concomitant corticosteroids (9, 10%). 37 patients (26%) were reported with moderate and severe COVID-19 course, third of them (13) on biologics. 24 patents (17%) were admitted for hospitalization, the rest managed in home setting (114, 79%) and hotels converted into makeshift healthcare facilities (6, 4%). Fifteen patients (10%) required non-invasive ventilation and oxygen support, 3 patients (2%) went on mechanical ventilation. All patients recovered uneventfully, with no mortalities reported. Age was the most significant factor associated with moderate and severe disease. We found no correlation between bowel disease activity and the severity of COVID-19 course. The rate of serious COVID-19 for the 94 patients who had received biologics was significantly lower than that of 50 patients who were not treated with biologics (13/94 vs 24/50; RR 0.29 [95% CI, 0.161–0.515]; p < 0.0001). On adjusting for age, gender, comorbidities, IBD phenotype and activity, the surprising ameliorating effect associated with biologics was profound and significant (OR, 0.082 [95% CI 0.009-0.621], p =0.013) in all age categories. Conclusion Our results are reassuring and encouraging, and do not suggest that therapeutic immune suppression renders IBD patients particularly vulnerable for more severe course of the COVID-19. Adjusted odds for severe COVID-19 course actually decreased significantly in patients treated with biologics. It could be speculated that cytokine inhibition may mitigate progression of the infection to a devastating hyperinflammatory state. Continuing necessary maintenance immune suppression seems to be appropriate and safe approach, despite the COVID-19 pandemic.

PURPOSE The prevalence of Helicobacter pylori gastritis has been declining, whereas H. pylori-negative gastritis has become more common. We evaluated chronic gastritis in children with regard to H. pylori status and celiac disease (CD). PATIENTS AND METHODS Demographic, clinical, endoscopic, and histologic features of children who underwent elective esophagogastroduodenoscopy were reviewed retrospectively. Gastric biopsies from the antrum and corpus of the stomach were graded using the Updated Sydney System. H. pylori presence was defined by hematoxylin and eosin, Giemsa, or immunohistochemical staining and urease testing. RESULTS A total of 184 children (61.9% female) met the study criteria with a mean age of 10 years. A total of 122 (66.3%) patients had chronic gastritis; 74 (60.7%) were H. pylori-negative. Children with H. pylori-negative gastritis were younger (p=0.003), were less likely to present with abdominal pain (p=0.02), and were mostly of non-Arabic origin (p=0.011). Nodular gastritis was found to be less prevalent in H. pylori-negative gastritis (6.8%) compared with H. pylori-positive gastritis (35.4%, p

Objective Different infectious agents have been presumed to be candidates acting as an etiologic factor or trigger of Crohn’s disease (CD). Group A Streptococcus (GAS) is a common human infection agent that can also trigger post-infectious immune-mediated conditions. The current study aimed to examine whether the immunogenic activity induced by GAS may trigger new-onset of CD. Methods Data for antistreptolysin O (ASO) level, throat culture for GAS, and history of streptococcal infection were collected from 91 patients with CD that were divided into three groups including; new-onset CD, CD in remission and active CD. The data were compared with the control group. Results All participants had negative results of throat culture for GAS and had no history of documented streptococcal infection in the past year. Our results indicate that new-onset CD, but not CD in remission or active CD, is associated with significantly increased positive ASO compared to controls. Half of the patients in the new-onset CD group were ASO positive, which was significantly higher compared to the control group in a univariant (OR: 4.00; 95% CI 1.27–12.58; P=0.02) and multivariant analysis (OR: 4.41; 95% CI 1.35–14.37; P=0.014). Conclusion Our study is the first to focus on ASO levels in patients with CD and to demonstrate a significant association between ASO and new-onset of CD. Large prospective randomized controlled studies are needed to confirm the validity of this data and to further clarify the clinical significance of our findings.

Background & Aims: Sense of coherence (SOC) is a theoretical concept reflecting a person‘s resources and orientation, which enable individuals to cope with stressors in a health-promoting manner. In several multifactorial chronic diseases, such as diabetes mellitus and systemic lupus erythematosus, SOC was correlated with disease development. It was also related with the emotional distress in patients with inflammatory boweldisease (IBD).The aim of this study was to investigate the possible correlation between low SOC scores and the presence of IBD.Methods: A total of 183 Crohn’s disease (CD) and 71 ulcerative colitis (UC) patients completed questionnaires including demographic data and the 13 items for the SOC questionnaire. The IBD patients were matched to 124 healthy people according to age, gender, education, employment status and marital status.Results: In the CD cohort, 96 patients were matched to the healthy cohort according to the propensity score value, and in the UC cohort 57 were matched. Patients with Crohns’ disease had a median SOC score of 63 (IQR 56-71), and healthy matching controls of 62.5 (IQR 55.25- 68.75) p=0.369. Patients with ulcerative patients had a median SOC score of 66 (IQR 56-73) and healthy controls 62 (IQR 55-69) p=0.354.Conclusions: In our study SOC was not related to the development of IBD. The question of whether SOC is associated with the development of chronic disease and particularly with IBD remains open.

Background The COVID-19 pandemic raised concerns among IBD patients fearing an increased risk of infection and poor outcomes. We aimed to evaluate the incidence of COVID-19 among IBD patients; its influence on disease severity and outcome; its relationship to medication use; and how the pandemic affected IBD management. Methods An anonymous questionnaire was posted online to members of the Israel Crohn’s Disease and Ulcerative Colitis Foundation (November 2020- January 2021). The questionnaire addressed the course of IBD disease and COVID-19 infection over the past year. Results 2152 IBD patients completed the questionnaire. 104 (4.8%) had been infected with COVID-19, significantly lower than the “expected” infected cases among the Israeli population (p=0.033). The median age of participants was 39; 60.5% were female. Most patients (75.6%) had no comorbidities other than IBD. No correlation was found between IBD type or disease severity and COVID-19 infection. Most IBD patients reported mild COVID-19 disease, regardless of the type of IBD medications. Multivariable logistic regression analysis revealed that younger age, elevated BMI, and diabetes were independent risk factors for COVID-19 infection. IBD treatment including 5-aminosalicylic acid, smoking, and hypertension were protective factors. 25.2% of COVID-19 patients discontinued their IBD treatment, compared to 8.5% of non-COVID-19 infected patients. IBD flares were significantly higher in those who discontinued treatment (p Conclusion IBD patients do not have an increased risk for COVID-19, regardless of IBD activity or treatment. Patients should be encouraged to continue effective IBD therapy, including biologics and steroids, to minimize active IBD.

Background IBD behaves differently among different ethnic groups. Patients perceptions and priorities for treatment outcome may well be influenced by their culture and beliefs. However, data on the impact of ethnicity on IBD patient’s attitude and expectation for treatment outcomes are still scares. We aimed to compare patient’s preferences and priorities for treatment outcomes among Jewish and Muslims IBD patients in Israel. Methods A prospective survey was conducted among Muslims IBD patients and compared to historical data set of Jewish IBD patients. Data included demographics and socioeconomics parameters as well as clinical data. Patients were asked to rank ten items regarding their preferences for treatment outcome, based on the ten IBD disk items. Cluster analysis was used to classify both patient’s groups into homogeneous subgroups according to their preferred IBD items. Results 391 patients were included in our analysis; 121 Muslims patients were compared to historical data base of 240 Jewish patients, 67.9% CD patients and 33.5% UC patients. Both groups were similar regarding age, disease activity and treatment, but the duration of disease was longer in the Jewish population (a median of 9 vs 6 years, p=0.01). As a group, Muslim patients ranked the priorities for treatment outcome lower compared to the Jewish population. The items with the highest priority were the same in both groups with abdominal pain, energy, and regular defecation ranking highest. There were no differences between Muslims men and women, but the Jewish women attached higher priority to abdominal pain, energy, sleep, joint pain, education and work. The cluster with the higher scores was characterized by more females (p Conclusion The ethnic difference has a high impact on patient’s ranking of priorities for treatment outcome. These differences can be explained by socioeconomic factors. Despite the ethnic and cultural differences, symptoms relief is in the highest priority in both patient groups.

ObjectiveTo formulate a decision analysis model based on recently published data that addresses the dilemma, whether improvement in quality of life rationalises continued proton pump inhibitors (PPI) use despite the risk of gastric cancer (GC) in patients with functional dyspepsia (FD).DesignA Markov model consisting of an initial decision regarding treatment with PPI (denoting it by PPI strategy) or any other treatment without PPI (denoting it by placebo strategy) was designed.Data sourcesData from prospective cross-sectional studies indicating risk stratification for GC after the use of PPI, combined with a Markov model that comprised the following states: Live, GC stages 1–4, Death.Outcome measuresThe primary outputs included quality-adjusted life years (QALYs) and life expectancy (LE). The improvement in utility in FD without PPI as compared with PPI use was tested (PPI vs placebo strategies). Sensitivity analyses were performed to evaluate the robustness of the model and address uncertainty in the estimation of model parameters.SettingWe considered only patients whose symptoms were relieved with PPIs and thus, had a better quality of life compared with patients who did not receive PPIs.ResultsThe base case model showed that PPIs compared with placebo decreased LE by 58.4 days with a gain of 2.1 QALY. If utility (quality of life of patients with FD using PPI compared with patients with FD without PPI) improved by more than 0.8%, PPI use is considered better than placebo. Older patients benefited less from PPI treatment than did younger patients.ConclusionTo bridge the gap between evidence and decision making, we found that even a small improvement in the QALY justified continuing PPI treatment.

Background The PAILOT trial was a randomised controlled trial aimed to evaluate proactive vs. reactive therapeutic drug monitoring in children with Crohn’s disease (CD) treated with adalimumab. Our aim, in this post-hoc analysis of the PAILOT trial, was to assess the efficacy and safety of adalimumab combination treatment in comparison to monotherapy at week 72 after adalimumab induction. Methods Participants were children 6–17 years old, biologic naïve, with moderate-to-severe CD, who responded to adalimumab induction at week 4. Patients receiving immunomodulators at baseline, maintained a stable dose until week 24; patients could then discontinue immunomodulators. At each visit patients were assessed for disease index, serum biomarkers, faecal calprotectin, adalimumab trough concentration and anti-adalimumab antibodies. Results Out of the 78 patients (29% female; mean age, 14.3 ± 2.6 years), 34 patients (44%) received combination therapy. During the study period there was no significant difference in the rates of sustained corticosteroid free clinical remission (25/34, 73% vs. 28/44, 63%; p = 0.35), and sustained composite outcome of clinical remission, CRP≤0.5 mg/dl and calprotectin≤150 µgr/gr (10/34, 29% vs. 14/44, 32%; p = 0.77) between the combination group and the monotherapy group, respectively. Clinical and biological outcomes did not differ between the proactive and reactive sub-groups within the combination and monotherapy groups. Adalimumab trough concentrations and immunogenicity were not significantly different between groups. The rate of serious adverse events was not significantly different between groups but numerically higher in the monotherapy group. Conclusion Combination therapy of adalimumab and an immunomodulator was not more effective than adalimumab monotherapy in children with CD.

Background Growth impairment is common in children with Crohn’s disease. We aimed to assess the effect of adalimumab treatment on linear growth in children with Crohn’s disease in a post-hoc analysis of the PAILOT randomised controlled trial. Methods Children 6–17 years old with moderate-to-severe Crohn’s disease, naïve to biologic treatment, who responded to adalimumab induction, were assessed at week 4, 8 andevery8 weeks thereafter until week 72 for anthropometric parameters (height, weight and body mass index, BMI, Z-scores). We also analysed the associations of these parameters with clinical disease activity, inflammatory biomarkers, faecal calprotectin and adalimumab trough concentration. Results Overall, 66 patients had available anthropometric parameters between week 4 to 72(29% females, mean age 14.3 ± 2.6 years). The median improvement of height z–score /month was +0.014, 95% CI 0.004–0.024, p = 0.006 with an overall improvement during the study period from -0.62 (IQR −1.6–0.15) to −0.33 (IQR -1.3–0.5). The median increase of weight z- score/month was +0.025, 95% CI 0.015–0.034, p = 0.025 [overall increase from -0.54 (IQR −1.2–0.15) to −0.1, (IQR -0.9–0.6)], whereas the median increase in BMI z –score/month was +0.02, 95% CI 0.008–0.031, p = 0.001 [overall increase from −0.4 (IQR −1.0–0.5) to 0.0 (IQR −0.8–0.9)]. There was a significant correlation between paediatric Crohn’s disease activity index and erythrocyte sedimentation rate at week 4 and height z-score changes (p = 0.043 and p = 0.048), respectively, and a marginal correlation with C-reactive protein (p = 0.06). There was a significant correlation between sustained clinical and biologic remission (weeks 4–72) and changes in height z-score during follow-up (p = 0.001). Faecal calprotectin, adalimumab trough concentrations and combination therapy with an immunomodulator were not associated with height z-score changes. Conclusion Adalimumab treatment significantly improved linear growth, and normalised weight and BMI in children with moderate-to-severe Crohn’s disease.

Introduction. Since individuals with IBD typically experience symptoms during their prime years of employment, it raises the question about IBD impact on employment status. Most studies concentrated on absenteeism from work with varying results in different populations. However, absenteeism reflects only one dimension of the ability to work and does not expose the problem of inability to hold a full-time job. Aims. To evaluate the influence of IBD on unemployment and working hours in Israel. Secondary aims were to investigate the correlation between working hours and the type of medical treatment and the impact of severity of disease. Patients and Methods. Demographic data, employment status, number of weekly working hours, and disease parameters. The data was compared to that of the general Israeli population extracted from the website of the Central Bureau of Statistics. Results. 242 IBD patients were interviewed. Patients median age was 37.04(IQR 30.23-44.68) years and 88 (36.4%) were men and 154 (63.6%) women. Diagnosis of CD was established in 167 (69%) patients and UC in 65 (26.9%). There was no significant reduction in employment rates or working hours among the IBD patients comparing to the general population. Immunosuppressive or biologic treatment did not influence employment status. The unemployed patients had higher disease severity (median 7.33, IQR 5-10.66) compared to employed patients (median 6, IQR 3.66-7.66; p=0.003). Conclusions. Although IBD patients in Israel do not have higher unemployment, those with severe disease have lower proportion of employment.

The aim was to present the workup of patients with acute recurrent pancreatitis (ARP) for genetic analysis and electrophysiological testing.Patients with ARP with unknown etiology were referred for genetic testing and evaluation of cystic fibrosis transmembrane conductor regulator (CFTR) function by nasal potential difference (NPD) testing.A total of 67 patients were evaluated. The mean age was 23 ± 17 years (median 17.0 years, range 1.5-72 years); 90% were Jewish and 10% Arab. Ten (15%) patients carried PRSS1 gene mutation (K23R(7), R122H(2), and D21A(1)). One patient had K172E/- (chymotrypsin C [CTRC]) mutation, 1 had I42M (serine protease inhibitor Kazal type 1 [SPINK1])/V235I (CTRC) together with ΔF508/5T, 1 patient had R67H (SPINK1)/V235I (CTRC), and 1 patient had V235I (CTRC)/-. Ten of 67 (15%) patients submitted for CFTR gene testing carried mutations (ΔF508/L997F, ΔF508/5T(11TG), W1282/5T(12TG), W1282X/Y1014C, ΔF508/R31C, R117H/-, R117H/Y1014C, D1152H/-, 5T(11TG)/-, and L997F/-). Fifty-four (80%) patients underwent sweat testing. Of these, 5 had sweat chloride ≥60 mEq/L, and 22 patients had sweat chloride from 40 to 60 mEq/L. Of the 56 (83%) patients had nasal potential difference testing, 4 (6%) with abnormal results.One-third (34%) of patients with ARP carry mutations for hereditary pancreatitis including rare mutations (K23R), and 12.5% have evidence of cftr mutations and 10% had CFTR dysfunction underscoring the importance of genetic and functional workup of these patients.