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Background/aims: Patients with diverticular disease (DD) frequently have abnormal bowel movements. However, it is unknown whether the entity of these alterations is associated with the severity of DD. We aimed to assess bowel habits and their relationship with the severity of DD according to Diverticular Inflammation and Complication Assessment (DICA) classification, Combined Overview on Diverticular Assessment (CODA) score, and fecal calprotectin (FC)., Methods: An international, multicenter, prospective cohort study was conducted in 43 centers. A 10-point visual analog scale (VAS) was used to assess the severity of constipation and diarrhea. The association of constipation and diarrhea with DICA classification, CODA score, and basal FC was tested using non-parametric tests. Survival methods for censored observations were applied to test the association of constipation and diarrhea with the incidence of acute diverticulitis over a 3-year follow-up., Results: Of 871 patients with DD were included in the study. Of these, 208 (23.9%) and 199 (22.9%) reported a VAS score for constipation and diarrhea at least 3 at baseline, respectively. Higher constipation and diarrhea scores were associated with increasing DICA classification, CODA score and basal FC (P< 0.001). Constipation and diarrhea scores were independently associated with an increased hazard of developing acute diverticulitis (hazard ratio [HR]constipation = 1.15 per 1-VAS point increase, 95% confidence interval [CI], 1.04-1.27; P=0.004; and HRdiarrhea =1.14; 95% CI, 1.03-1.26; P=0.014, respectively)., Conclusions: In newly diagnosed patients with DD, higher endoscopic and combined scores of DD severity were associated with higher scores of constipation and diarrhea at baseline. Both constipation and diarrhea were independent prognostic factors of acute diverticulitis.

The Brazilian Organization for Crohn's Disease and Colitis (GEDIIB) established a national registry of inflammatory bowel disease (IBD). The aim of the study was to identify clinical factors associated with disease severity in IBD patients in Brazil. A population-based risk model aimed at stratifying the severity of IBD based on previous hospitalization, use of biologics, and need for surgery for ulcerative colitis (UC) and Crohn's Disease (CD) and on previous complications for CD. A total of 1179 patients (34.4 ± 14.7y; females 59%) were included: 46.6% with UC, 44.2% with CD, and 0.9% with unclassified IBD (IBD-U). The time from the beginning of the symptoms to diagnosis was 3.85y. In CD, 41.2% of patients presented with ileocolic disease, 32% inflammatory behavior, and 15.5% perianal disease. In UC, 46.3% presented with extensive colitis. Regarding treatment, 68.1%, 67%, and 47.6% received biological therapy, salicylates and immunosuppressors, respectively. Severe disease was associated with the presence of extensive colitis, EIM, male, comorbidities, and familial history of colorectal cancer in patients with UC. The presence of Montreal B2 and B3 behaviors, colonic location, and EIM were associated with CD severity. In conclusion, disease severity was associated with younger age, greater disease extent, and the presence of rheumatic EIM., (© 2024. The Author(s).)

Introduction: We assessed the prevalence and clinical outcomes of segmental colitis associated with diverticulosis (SCAD) in patients with newly diagnosed diverticulosis., Methods: A 3-year international, multicenter, prospective cohort study was conducted involving 2,215 patients., Results: SCAD diagnosis was posed in 44 patients (30 male patients; median age: 64.5 years; prevalence of 1.99%, 95% confidence interval, 1.45%-2.66%). Patients with SCAD types D and B showed worse symptoms, higher fecal calprotectin values, needed more steroids, and reached less likely complete remission., Discussion: Although SCAD generally had a benign outcome, types B and D were associated with more severe symptoms and worse clinical course., (Copyright © 2023 by The American College of Gastroenterology.)

Background and Aims: The Diverticular Inflammation and Complication Assessment (DICA) classification and the Combined Overview on Diverticular Assessment (CODA) were found to be effective in predicting the outcomes of Diverticular Disease (DD). We ascertain whether fecal calprotectin (FC) can further aid in improving risk stratification., Methods: A three-year international, multicentre, prospective cohort study was conducted involving 43 Gastroenterology and Endoscopy centres. Survival methods for censored observations were used to estimate the risk of acute diverticulitis (AD) in newly diagnosed DD patients according to basal FC, DICA, and CODA. The net benefit of management strategies based on DICA, CODA and FC in addition to CODA was assessed with decision curve analysis, which incorporates the harms and benefits of using a prognostic model for clinical decisions., Results: At the first diagnosis of diverticulosis/DD, 871 participants underwent FC measurement. FC was associated with the risk of AD at 3 years (HR per each base 10 logarithm increase: 3.29; 95% confidence interval, 2.13-5.10) and showed moderate discrimination (c-statistic: 0.685; 0.614-0.756). DICA and CODA were more accurate predictors of AD than FC. However, FC showed high discrimination capacity to predict AD at 3 months, which was not maintained at longer follow-up times. The decision curve analysis comparing the combination of FC and CODA with CODA alone did not clearly indicate a larger net benefit of one strategy over the other., Conclusions: FC measurement could be used as a complementary tool to assess the immediate risk of AD. In all other cases, treatment strategies based on the CODA score alone should be recommended., (© 2023 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)

Objective: To investigate the predictive value of the Diverticular Inflammation and Complication Assessment (DICA) classification and to develop and validate a combined endoscopic-clinical score predicting clinical outcomes of diverticulosis, named Combined Overview on Diverticular Assessment (CODA)., Design: A multicentre, prospective, international cohort study., Setting: 43 gastroenterology and endoscopy centres located in Europe and South America., Participants: 2215 patients (2198 completing the study) at the first diagnosis of diverticulosis/diverticular disease were enrolled. Patients were scored according to DICA classifications., Interventions: A 3-year follow-up was performed., Main Outcome Measures: To predict the acute diverticulitis and the surgery according to DICA classification. Survival methods for censored observation were used to develop and validate a novel combined endoscopic-clinical score for predicting diverticulitis and surgery (CODA score)., Results: The 3-year cumulative probability of diverticulitis and surgery was of 3.3% (95% CI 2.5% to 4.5%) in DICA 1, 11.6% (95% CI 9.2% to 14.5%) in DICA 2 and 22.0% (95% CI 17.2% to 28.0%) in DICA 3 (p<0.001), and 0.15% (95% CI 0.04% to 0.59%) in DICA 1, 3.0% (95% CI 1.9% to 4.7%) in DICA 2 and 11.0% (95% CI 7.5% to 16.0%) in DICA 3 (p<0.001), respectively. The 3-year cumulative probability of diverticulitis and surgery was ≤4%, and ≤0.7% in CODA A; <10% and <2.5% in CODA B; >10% and >2.5% in CODA C, respectively. The CODA score showed optimal discrimination capacity in predicting the risk of surgery in the development (c-statistic: 0.829; 95% CI 0.811 to 0.846) and validation cohort (c-statistic: 0.943; 95% CI 0.905 to 0.981)., Conclusions: DICA classification has a significant role in predicting the risk of diverticulitis and surgery in patients with diverticulosis, which is significantly enhanced by the CODA score., Trial Registration Number: NCT02758860., Competing Interests: Competing interests: SD served as speaker, consultant and/or advisory board member for AbbVie, Allergan, Alfa Wassermann, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Gilead, Hospira, Johnson and Johnson, Merck, MSD, Mundipharma, Pfizer, Sandoz, Takeda, Tigenix, UCB Pharma, Vifor. GM served as speaker and/or advisory board fees for AlfaSigma, Arena, Janssen, Gilead, Roche. GN received funding for target projects from Apharm and Sofar. APserved as lecturer for AlfaSigma and Polpharma. JR served as lecturer for AlfaSigma, Takeda, Ipsen and Servier. FS served as lecturer for Sanofi., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The effectiveness of ustekinumab (UST) in the treatment of Crohn's disease (CD) has been demonstrated in the pivotal Phase 3 UNITI 1 and 2 and IM-UNITI studies in both anti-TNF-naïve and anti-TNF-exposed patients. Given the selective nature of pivotal trial designs, real-world effectiveness and safety studies are warranted. We report our experience with UST treatment in a large, real-world multicenter cohort of Brazilian patients with CD., Methods: We performed a retrospective multicenter study including patients with CD, predominantly biologically refractory CD, who received UST. The primary endpoint was the proportion of patients in clinical remission at weeks 8, 24 and 56. Possible predictors of clinical and biological response/remission and safety outcomes were also assessed., Results: Overall, 245 CD (mean age 39.9 [15-87]) patients were enrolled. Most patients (86.5%) had been previously exposed to biologics. According to nonresponder imputation analysis, the proportions of patients in clinical remission at weeks 8, 24 and 56 were 41.0% (n = 98/239), 64.0% (n = 153/239) and 39.3% (n = 94/239), respectively. A biological response was achieved in 55.4% of patients at week 8, and 59.3% were in steroid-free remission at the end of follow-up. No significant differences in either clinical or biological remission were noted between bio-naïve and bio-experienced patients. Forty-eight patients (19.6%) presented 60 adverse events during the follow-up, of which 8 (13.3%) were considered serious adverse events (3.2% of 245 patients). Overall, a proximal disease location, younger age, perianal involvement, and smoking were associated with lower rates of clinical remission over time., Conclusions: UST therapy was effective and safe in the long term in this large real-life cohort of Brazilian patients with refractory CD, regardless of previous exposure to other biological agents., (© 2022. The Author(s).)

Background: The IBD National Patient Registry is an initiative of the GEDIIB (Brazilian Study Group of Inflammatory Bowel Disease) who aims to survey the epidemiological profile of IBD patients through the creation of a centralized registry with data on patients monitored in public and private health services which will allow the planning of actions by the GEDIIB to facilitate the diagnosis and access to treatment of IBD, enabling the implementation of actions of the GEDIIB and the partnership with government agencies to improve care and, consequently, the quality of life of patients with IBD. This study aims to show the results of the IBD National Patient Registry., Methods: A cohort study was performed. Data were collected from July 2020 to August 2021. Data were obtained from medical records and/or from patients during the regular follow-up visit and stored in pre-established records for further analysis. Only patients with an established diagnosis of CD and UC were included. The study was approved by the local ethical committees and all patients signed the consent form., Results: In total, 797 patients were included, 60% with UC and 40% with CD; 52.9% from University Hospitals. The mean age was 44.75 ± 16.11 (12 - 92y), 59.9% female, 59.3% married, 76.4% Caucasian, 85.1% non-smokers, 30.5% completed higher education, 14.9% presented familial history of IBD. The age of onset of symptoms ranged from 3 - 79 years (32.94 ± 14.22) and 33.2% presented diarrhea as an initial manifestation. The age of diagnosis ranged from 4 - 81 years (35.07 ± 14.60) and the time from symptoms to diagnosis ranged from 1 to 2 years. The Montreal classification of CD patients were A1: 6.3%, A2: 59.9%, A3: 33.8%; L1: 38%, L2: 16.7%, L3: 43.9%, B1: 51.5%, B2: 27.8%, B3: 7.8%; perianal 12.8%. In UC, 47.8% presented pancolitis, 30.3% left-sided and 21.8% distal colitis. EIMs were present in 45.7% of patients, the most frequent being rheumatological 21.8%. Comorbidities were present in 72%, the most frequent were high blood pressure (15.3%) and diabetes (6.3%); 50% were with BMI > 25 Kg/m2. Most of the patients were in use of medical therapy (95.5%), of which 81.3% salicylate, 70.3% biological therapy, 49% immunosuppressor, 25.6% corticosteroid and 1.2% tofacitinib. Regarding biological therapy, the following medications were used: infliximab 47.6%, adalimumab 28.4%, vedolizumab 9.5%, ustekinumab 7.5%, certolizumab 2.2% and golimumab 1.3%. Eleven women used the medication during pregnancy. IBD surgery-related was performed in 69.7%, 77.2% abdominal and 22.8% perianal. Almost 30% performed more than one surgery. In 62% of patients, at least one complication was reported; most of them were infective disorders, demanding prolonged hospitalizations., Conclusion: To date, there is no IBD epidemiologic study covering the entire Brazilian territory. The results found with the registry will be fundamental to show the epidemiology of a country with continental dimensions such as Brazil. The greater the number of researchers included and from different regions of the country, the greater the representativeness of the data and may even help direct government actions on behalf of IBD patients., (Copyright © 2021 by The American College of Gastroenterology.)

Background: Crohn's disease (CD) and ulcerative colitis (UC) are inflammatory bowel diseases (IBDs) with a remission-relapsing presentation and symptomatic exacerbations that have detrimental impacts on patient quality of life and are associated with a high cost burden, especially in patients with moderate-to-severe disease. The Real-world Data of Moderate-to-Severe Inflammatory Bowel Disease in Brazil (RISE BR) study was a noninterventional study designed to evaluate disease control, treatment patterns, disease burden and health-related quality of life in patients with moderate-to-severe active IBD. We report findings from the prospective follow-up phase of the RISE BR study in patients with active UC or CD., Aim: To describe the 12-mo disease evolution and treatment patterns among patients with active moderate-to-severe IBD in Brazil., Methods: This was a prospective, noninterventional study of adult patients with active Crohn's disease (CD: Harvey-Bradshaw Index ≥ 8, CD Activity Index ≥ 220), inadequate CD control ( i.e., calprotectin > 200 µg/g or colonoscopy previous results), or active ulcerative colitis (UC: Partial Mayo score ≥ 5). Enrollment occurred in 14 centers from October 2016 to February 2017. The proportion of active IBD patients after 9-12 mo of follow-up, Kaplan-Meier estimates of the time to mild or no activity and a summary of treatment initiation, discontinuation and dose changes were examined., Results: The study included 118 CD and 36 UC patients, with mean ± SD ages of 43.3 ± 12.6 and 44.9 ± 16.5 years, respectively. The most frequent drug classes at index were biologics for CD (62.7%) and 5-aminosalicylate derivates for UC patients (91.7%). During follow-up, 65.3% of CD and 86.1% of UC patients initiated a new treatment at least once. Discontinuations/dose changes occurred in 68.1% of CD patients [median 2.0 (IQR: 2-5)] and 94.3% of UC patients [median 4.0 (IQR: 3-7)]. On average, CD and UC patients had 4.4 ± 2.6 and 5.0 ± 3.3 outpatient visits, respectively. The median time to first mild or no activity was 319 (IQR: 239-358) d for CD and 320 (IQR: 288-358) d for UC patients. At 9-12 mo, 22.0% of CD and 20.0% of UC patients had active disease., Conclusion: Although a marked proportion of active IBD patients achieved disease control within one year, the considerable time to achieve this outcome represents an unmet medical need of the current standard of care in a Brazilian real-world setting., Competing Interests: Conflict-of-interest statement: Ligia Yukie Sassaki has received fees for serving as a speaker for AbbVie and Takeda. Sender Jankiel Miszputen has received fees for serving as a speaker and/or a consultant for Farmoquimica, Janssen and Marjan. He has received research funding from Ache, Roche and Takeda. Wilson Roberto Catapani has received fees for serving as a speaker and/or an advisory board member for Janssen and Takeda. Mauro Bafutto has received fees for serving as a speaker for Takeda, AbbVie, Janssen, UCB and Farmoquimica. He has received fees for serving as an advisory board member for AbbVie and Janssen. Antonio Scafuto Scotton has received fees for serving as a speaker for Janssen, Novartis, AbbVie, MSD, EMS. He has received research funding from Janssen, Novartis, AbbVie, Roche, Pfizer, Bristol, Lilly, Novo Nordisk, Anthera, AstraZeneca, GSK, UCB, Sanofi, Takeda, Parexel, IQVIA, PPD, PRA, ICON, INP Research, Covance, In Trials. Cyrla Zaltman has received fees for serving as a speaker for UCB, Janssen, Takeda, AbbVie. She has received research funding from AbbVie, Takeda, Janssen. Julio Pinheiro Baima has received fees for serving as a speaker for Janssen and Takeda. Cristina Flores has received fees for serving as a speaker for Janssen, Takeda, AbbVie. She has received fees for serving as an advisory board member for Janssen. Rodrigo Bremer Nones has received fees for serving as a speaker for AbbVie, Ferring Pharmaceuticals, Janssen, Nestle, Novartis, Pfizer, UCB Pharma and Takeda. Jose Miguel Luz Parente has received fees for serving as a speaker for Takeda. Julio Maria Fonseca Chebli has received fees for serving as a speaker for AbbVie, Janssen, UCB Pharma and Takeda. Maria de Lourdes de Abreu Ferrari has received fees for serving as a speaker and/or advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, UCB Pharma, and Takeda. Rogerio Serafim Parra has received fees for serving as a speaker and/or an advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, UCB Pharma and Takeda. Jose Joaquim Ribeiro da Rocha has received fees for serving as a speaker for Nestle. Marley Ribeiro Feitosa has received fees for serving as a speaker for AbbVie and Janssen. Rosana Fusaro Caratin was an employee of Takeda Pharmaceuticals Brazil at the time the manuscript was developed. Juliana Tosta Senra is an employee of Takeda Pharmaceuticals Brazil. Genoile Oliveira Santana has received fees for serving as a speaker for Takeda, AbbVie, Janssen, UCB Pharma. She has received research funding from Celgene and Roche. She has received fees for serving as an advisory board member for Janssen. No conflict of interest: Roberto Luiz Kaiser Junior, Mikaell Alexandre Gouvea Faria, Carolina Dias Goncalves, Isabella de Miranda Guimaraes, Heda Maria Barska dos Santos Amarante, Murilo Moura Lima, Odery Ramos, Omar Feres, Hagata Souza Ramos, Julia Faria Campos, and Maria das Gracas Pimenta Sanna., (©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background: Understanding the treatment landscape of inflammatory bowel diseases (IBD) is essential for improving disease management and patient outcomes. Brazil is the largest Latin American country, and it presents socioeconomic and health care differences across its geographical regions. This country has the highest increase in IBD incidence and prevalence in Latin America, but information about the clinical and treatment characteristics of IBD is scarce., Aim: To describe the sociodemographic, clinical, and treatment characteristics of IBD outpatients in Brazil overall and in the Southeast, South and Northeast/Midwest regions., Methods: Multicenter, cross-sectional study with a 3-year retrospective chart review component. Patients with moderate-to-severe Crohn's disease (CD) or ulcerative colitis (UC) were consecutively enrolled between October 2016 and February 2017. Active CD at enrollment was defined as a Harvey Bradshaw Index ≥ 8 or a CD Activity Index ≥ 220 or a calprotectin level > 200 μg/g or an active result based on colonoscopy suggestive of inadequate control during the previous year; active UC was defined as a partial Mayo score ≥ 5. Descriptive statistics were used to analyze all variables., Results: In a total of 407 included patients, CD was more frequent than UC, both overall (264 CD/143 UC patients) and by region (CD:UC ratios of 2.1 in the Southeast, 1.6 in the South and 1.2 in the Northeast/Midwest). The majority of patients were female (54.2% of CD; 56.6% of UC), and the mean ages were 45.9 ± 13.8 years (CD) and 42.9 ± 13.0 years (UC). The median disease duration was 10.0 (range: 0.5-45) years for both IBD types. At enrollment, 44.7% [95% confidence interval (CI): 38.7-50.7] of CD patients and 25.2% (95%CI: 18.1-32.3) of UC patients presented with active disease. More than 95% of IBD patients were receiving treatment at enrollment; CD patients were commonly treated with biologics (71.6%) and immunosuppressors (67.4%), and UC patients were commonly treated with mesalazine [5-Aminosalicylic acid (5-ASA)] derivates (69.9%) and immunosuppressors (44.1%). More than 50% of the CD patients had ileocolonic disease, and 41.7% presented with stricturing disease. One-quarter of CD patients had undergone CD-related surgery in the past 3 years, and this proportion was lower in the Northeast/Midwest region (2.9%)., Conclusion: In Brazil, there are regional variations in IBD management. CD outweighs UC in both frequency and disease activity. However, one-quarter of UC patients have active disease, and most are receiving 5-ASA treatment., Competing Interests: Conflict-of-interest statement: Cyrla Zaltman has received speaker fees from AbbVie, Janssen, Pfizer, UCB Pharma and Takeda, and received research funding from AbbVie, Takeda, and Janssen; Rogerio Serafim Parra has received fees for serving as speaker or as an advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, UCB Pharma and Takeda; Ligia Yukie Sassaki has received speaker fees from AbbVie and Takeda; Genoile Oliveira Santana has received speaker fees from AbbVie, Janssen, Takeda and UCB Pharma; and received research funding from Celgene, Roche and Takeda; Maria de Lourdes Abreu Ferrari has received fees for serving as a speaker or as an advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, UCB Pharma, and Takeda; Sender Jankiel Miszputen has received fees for serving as speaker or as a consultant for Farmoquimica, Janssen and Marjan, and received research funding from Ache, Roche and Takeda; Cristina Flores has received speaker fees from Janssen, Takeda, and AbbVie; and received fees for serving as an advisory board member for Janssen; Wilson Roberto Catapani has received fees for serving as a speaker or as an advisory board member for Janssen and Takeda; Jose Miguel Luz Parente has received speaker fees from Takeda; Mauro Bafutto has received speaker fees from Takeda, AbbVie, Janssen, UCB and Farmoquimica; and received fees for serving as an advisory board member for AbbVie and Janssen; Jose Joaquim Ribeiro da Rocha has received speaker fees from Nestle; Marley Ribeiro Feitosa has received speaker fees from Janssen and Nestle, and fees for scientific congresses’ support by Janssen, AbbVie, Takeda, Ferring and Nestle and was a subinvestigator in scientific studies sponsored by Janssen, AbbVie and Takeda; Rogerio Saad Hossne has received speaker fees from AbbVie, Janssen, Pfizer and Takeda; Francisco Guilherme Cancela e Penna has received speaker fees from Janssen, Takeda, AbbVie and UCB; Tarcia Nogueira Ferreira Gomes has received research funding from Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior and Takeda; and has received speaker fees from Janssen; Rodrigo Bremer Nones has received speaker fees from AbbVie, Ferring Pharmaceuticals, Janssen, Nestle, Novartis, Pfizer, UCB Pharma and Takeda; Antonio Scafuto Scotton has received speaker fees from Janssen, Novartis, AbbVie, MSD, and EMS, and has received research funding from Janssen, Novartis, AbbVie, Roche, Pfizer, Bristol, Lilly, Novo Nordisk, Anthera, AstraZeneca, GSK, UCB, Sanofi, Takeda, Parexel, IQVIA, PPD, PRA, ICON, INP Research, Covance, and In Trials; Rosana Fusaro Caratin was an employee at Takeda Pharmaceuticals Brazil at the time of the study and when this manuscript was written; Juliana Tosta Senra is an employee at Takeda Pharmaceuticals Brazil; Julio Maria Fonseca Chebli has received speaker fees from AbbVie, Janssen, UCB Pharma and Takeda; Heda Maria Barska dos Santos Amarante, Roberto Kaiser Junior, Odery Ramos, Carolina Dias Gonçalves, Isabella de Miranda Guimaraes, Omar Feres, Mikaell Alexandre Gouvea Faria, Pedro Ferrari Sales da Cunha, Mírian Perpétua Palha Dias Parente declare that they have no conflict of interest, (©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background: Vitamin D (VD) has an important role in regulating gut mucosal immunity, and seems to be inversely linked to disease activity and more frequent relapses in inflammatory bowel disease. In this study, we evaluated patients with Crohn's disease (CD) treated with anti-tumor necrosis factor (TNF) in association with VD., Methods: A double-blind, randomized, prospective study was conducted. Thirty patients with a history of moderate to severe CD, in use of anti-TNF, of both sexes, 18 to 70 years, with the dosage of VD < 75 nmol/L (30 ng/mL) were randomized and divided into three groups: group 1 (G1): 10 patients received 2,000 IU VD, per os (PO)/week for 8 weeks; group 2 (G2): 10 patients received 10,000 IU VD, PO/week for 8 weeks; group 3 (G3): 10 patients received 50,000 IU VD, PO/week for 8 weeks. Before and at the end of 8 weeks patients were submitted to VD, fecal calprotectin (FC) and C-reactive protein (CRP) dosage. Follow-up period was 52 weeks, and they are checked for disease activity recurrence (Crohn's disease activity index (CDAI) > 150, FC > 300 and computerized tomography (CT) scan), FC, CRP, and VD levels., Results: Increased VD levels were observed in all groups (P < 0.0001). CRP did not change. There was a significant decrease of FC in G3 (1,014 ± 850 vs. 483 ± 564; P = 0.04), no significant decrease in G2 (76,767 ± 751 vs. 535 ± 823; P = 0.2) and increase in G1 (1,101 ± 744 vs. 1,357 ± 819; P = 0.4). During the 52-week follow-up period, it was showed that recurrent disease activity (CDAI > 150, FC > 200 and CT scan) was predominant in patients with VD < 30 group, and the remission rate was predominant in patients with VD > 30 group (P = 0.0001). A statistically significant difference in VD levels was noted in CD patients after 52 weeks that presented flare or disease remission (P = 0.001)., Conclusions: Use of VD associated with anti-TNF treatment may improve clinical response in CD. VD levels greater than 30 ng/mL have better rates of remission., Competing Interests: All authors have no conflict of interest to declare., (Copyright 2020, Bafutto et al.)

Symptomatic Uncomplicated Diverticular Disease (SUDD) is the most common clinical form of Diverticular Disease (DD). The therapy should be aimed at reducing both the intensity and frequency of symptoms as well as preventing complications. The pharmacological treatments include fibers, not absorbable antibiotics (for example rifaximin), anti-inflammatory drugs (for example 5-amino-salycilic acid) and probiotics, alone or in combination with other drugs. Although some of these treatments seem to be effective in treating SUDD, but their efficacy in preventing complications of the disease is still uncertain. It has been hypothesized that microbial imbalance associated with bacterial overgrowth of the colon, may be the key to the development of diverticular disease (DD). Therefore, drugs that can manipulate gut microbiota such as probiotics or rifaximine are considered as a potential key therapy. Rifaximine is able to modulate the intestinal ecosystem, restoring eubiosis. Traditionally, DD of the colon is thought to be related to low grade of inflammation. By analogy with other inflammatory bowel diseases mesalazine has been studied also in DD. There are several evidences that may support the use of mesalazine in the SUDD. Unfortunately, mesalazine cannot be used to prevent diverticulitis because of the paucity of high-quality studies. Currently, mesalazine has a limited place for the management of SUDD. In SUDD probiotics have been proven as an effective therapy in reducing abdominal symptoms, but unfortunately there has been limited number of relevant studies regarding efficacy of this therapy.

The statements produced by the Chairmen and Speakers of the 3rd International Symposium on Diverticular Disease, held in Madrid on April 11th-13th 2019, are reported. Topics such as current and evolving concepts on the pathogenesis, the course of the disease, the news in diagnosing, hot topics in medical and surgical treatments, and finally, critical issues on the disease were reviewed by the Chairmen who proposed 39 statements graded according to level of evidence and strength of recommendation. Each topic was explored focusing on the more relevant clinical questions. The vote was conducted on a 6-point scale and consensus was defined a priori as 67% agreement of the participants. The voting group consisted of 124 physicians from 18 countries, and agreement with all statements was provided. Comments were added explaining some controversial areas.

Background: Inflammatory bowel diseases (IBD) have been associated with a low quality of life (QoL) and a negative impact on work productivity compared to the general population. Information about disease control, patient-reported outcomes (PROs), treatment patterns and use of healthcare resources is relevant to optimizing IBD management., Aim: To describe QoL and work productivity and activity impairment (WPAI), treatment patterns and use of healthcare resources among IBD patients in Brazil., Methods: A multicenter cross-sectional study included adult outpatients who were previously diagnosed with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC). At enrolment, active CD and UC were defined as having a Harvey Bradshaw Index ≥ 8 or a CD Activity Index ≥ 220 or calprotectin > 200 µg/g or previous colonoscopy results suggestive of inadequate control (per investigator criteria) and a 9-point partial Mayo score ≥ 5, respectively. The PRO assessment included the QoL questionnaires SF-36 and EQ-5D-5L, the Inflammatory Bowel Disease Questionnaire (IBDQ), and the WPAI questionnaire. Information about healthcare resources and treatment during the previous 3 years was collected from medical records. Chi-square, Fisher's exact and Student's t -/Mann-Whitney U tests were used to compare PROs, treatment patterns and the use of healthcare resources by disease activity (α = 0.05)., Results: Of the 407 patients in this study (CD/UC: 64.9%/35.1%, mean age 42.9/45.9 years, 54.2%/56.6% female, 38.3%/37.1% employed), 44.7%/25.2% presented moderate-to-severe CD/UC activity, respectively, at baseline. Expressed in median values for CD/UC, respectively, the SF-36 physical component was 46.6/44.7 and the mental component was 45.2/44.2, the EQ-visual analog scale score was 80.0/70.0, and the IBDQ overall score was 164.0/165.0. Moderate to severe activity, female gender, being unemployed, a lower educational level and lower income were associated with lower QoL ( P < 0.05). Median work productivity impairment was 20% and 5% for CD and UC patients, respectively, and activity impairment was 30%, the latter being higher among patients with moderate to severe disease activity compared to patients with mild or no disease activity (75.0% vs 10.0%, P < 0.001). For CD/UC patients, respectively, 25.4%/2.8% had at least one surgery, 38.3%/19.6% were hospitalized, and 70.7%/77.6% changed IBD treatment at least once during the last 3 years. The most common treatments at baseline were biologics (75.3%) and immunosuppressants (70.9%) for CD patients and 5-ASA compounds (77.5%) for UC patients., Conclusion: Moderate to severe IBD activity, especially among CD patients, is associated with a substantial impact on QoL, work productivity impairment and an increased number of IBD surgeries and hospitalizations in Brazil., Competing Interests: Conflict-of-interest statement: Parra RS has received fees for serving as a speaker and/or an advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, UCB Pharma and Takeda. Saad-Hossne R has received fees for serving as a speaker for AbbVie, Janssen, Pfizer and Takeda. Miszputen S has received fees for serving as a speaker and/or a consultant for Farmoquimica, Janssen and Marjan. He has received research funding from Ache, Roche and Takeda. Fernandes M is an employee of Eurotrials, now part of CTI, a CRO that provides services for pharmaceutical laboratories. Catapani WR has received fees for serving as a speaker and/or an advisory board member for Janssen and Takeda. Sassaki LY has received fees for serving as a speaker for AbbVie and Takeda. Gomes TNF has received research funding from Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior (CAPES) and Takeda. She has received fees for serving as a speaker for Janssen. Chebli JMF has received fees for serving as a speaker for AbbVie, Janssen, UCB Pharma and Takeda. Senra JT and Caratin RF are employees of Takeda Pharmaceuticals Brazil. Nones RB has received fees for serving as a speaker for AbbVie, Ferring Pharmaceuticals, Janssen, Nestle, Novartis, Pfizer, UCB Pharma and Takeda. Parente JML has received fees for serving as a speaker for Takeda. Ferrari MLA has received fees for serving as a speaker and/or advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, UCB Pharma, and Takeda. Santana GO has received fees for serving as a speaker for Takeda, AbbVie, Janssen, and UCB Pharma. She has received research funding from Celgene and Roche. She has received fees for serving as an advisory board member for Janssen. Rocha JJR has received fees for serving as a speaker for Nestle. Feitosa MR has received fees for serving as a speaker for AbbVie and Janssen. Scotton AS has received fees for serving as a speaker for Janssen, Novartis, AbbVie, MSD, and EMS. He has received research funding from Janssen, Novartis, AbbVie, Roche, Pfizer, Bristol, Lilly, Novo Nordisk, Anthera, AstraZeneca, GSK, UCB, Sanofi, Takeda, Parexel, IQVIA, PPD, PRA, ICON, INP Research, Covance, and In Trials. Flores C has received fees for serving as a speaker for Janssen, Takeda, and AbbVie. She has received fees for serving as an advisory board member for Janssen. Zaltman C has received fees for serving as a speaker for UCB, Janssen, Takeda, and AbbVie. She has received research funding from AbbVie, Takeda, and Janssen. Bafutto M has received fees for serving as a speaker for Takeda, AbbVie, Janssen, UCB and Farmoquimica. He has received fees for serving as an advisory board member for AbbVie and Janssen. No conflict-of-interest: Omar Feres, Murilo Moura Lima, Roberto Luiz Kaiser Junior, Carolina Dias Gonçalves, Stella Cristina Silva de Souza, Anderson Antonio de Faria, Isabella de Miranda Guimaraes, Heda Maria Barska dos Santos Amarante, Mikaell Alexandre Gouvea Faria, Odery Ramos Junior., (©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background: Psoriasis is an inflammatory skin disease that affects 1%-3% of Caucasian populations and may be persistent, disfiguring and stigmatising. Proton pump inhibitors (PPI) are potent blockers of gastric acid secretion. They are widely regarded as the agents of choice for the treatment of acid-peptic disorders. In addition to anti-secretory effects PPI have been found to have anti-oxidant properties and direct effects on neutrophils, monocytes, endothelial, and epithelial cells that might prevent inflammation., Objective: This study evaluated the treatment of psoriasis with esomeprazole., Methods: Ten patients were selected and psoriasis was evaluated according to Psoriasis Area and Severity Index (PASI). Exclusion criteria included concomitant use of any treatment for Psoriasis, organic diseases, use of other PPI than esomeprazole. Patients were medicated with esomeprazole 40 mg B.I.D. for 90 days. At the 90th day the patients were evaluated according PASI score., Results: Statistically significant results were seen when compared PASI before and at 90th day of treatment (P=0.0002)., Conclusion: The use of esomeprazole for psoriasis resulted in excellent clinical results with a significant reduction of PASI score.

Background: Constipation is the main symptom of acquired chagasic megacolon. However, a number of patients with Chagas disease without colon involvement also have the same complain. This study evaluated the role of small bowel in constipated patients with Chagas disease with and without megacolon., Methods: Orocecal transit time (OCTT) and oral glucose tolerance test (OGTT) in constipated non-chagasic and chagasic patients with and without megacolon were performed. One hundred fifteen patients were included in this study and were divided into two groups based on the presence or absence of constipation, which is defined as at least 7 days without bowel movements for more than 1 year. These two groups were further divided into three subgroups based on the serology test results for Trypanosoma cruzi and the presence and absence of megacolon on barium enema. All patients were subjected to OCTT and OGTT., Results: Among 70 constipated patients, 64.3% had OCTT longer than 120 min, higher than the non-constipated patients (31.1%, P < 0.000). The proportion of patients within the three subgroups in the non-constipated group was not different from each other (P = 0.345). Among the constipated subgroup, 94.44% of the chagasic megacolon subgroup had OCTT longer than 120 min, higher than the other two subgroups (P = 0.005). Chagas patients with constipation, without or without megacolon, showed higher blood glucose levels at 30, 60, and 90 min after oral ingestion of 70 g glucose than normal subjects with or without constipation., Conclusions: Constipated, either non-chagasic or chagasic, patients have a prolonged OCTT. This result suggests that slow small bowel transit may be a significant factor for constipation., Competing Interests: The authors declare that they have no conflicts of interest.

Diverticular disease is a very common entity affecting the elders, but also a few people in the young age group. Most patients are asymptomatic, but about 30% of them will have abdominal complaints. As the pathophysiology of diverticular disease has changed since its description, we address some important points about the disease. Recent knowledge has changed the way we treat the patients with diverticular disease: conservatively or surgically.

Surgical treatment of diverticulitis is still characterized by high morbidity and mortality. Surgical approach evolved from the early 20th century with 3-stage laparotomy to colon resection with primary anastomosis. In the last 2 decades, laparoscopic colectomy has been applied to elective and emergency setting of diverticular disease. Recently, laparoscopic lavage and drainage has been used to treat purulent peritonitis. All those modalities of treatment have been discussed and pointed pros and cons.

Background: Primary hypolactasia is a common condition where a reduced lactase activity in the intestinal mucosa is present. The presence of abdominal symptoms due to poor absorption of lactose, which are present in some cases, is a characteristic of lactose intolerance., Objective: Evaluate the efficacy of a product containing exogenous lactase in tablet form compared to a reference product with proven effectiveness in patients with lactose intolerance., Methods: Multicentre, randomized, parallel group, single-blind, comparative non-inferiority study. One hundred twenty-nine (129) adult lactose intolerance patients with hydrogen breath test results consistent with a diagnosis of hypolactasia were randomly assigned to receive the experimental product (Perlatte(r) - Eurofarma Laboratórios S.A.) or the reference product (Lactaid(r) - McNeilNutritionals, USA) orally (one tablet, three times per day) for 42 consecutive days., Results: Data from 128 patients who actually received the studied treatments were analysed (66 were treated with the experimental product and 62 with the reference product). The two groups presented with similar baseline clinical and demographic data. Mean exhaled hydrogen concentration tested at 90 minutes after the last treatment (Day 42) was significantly lower in the experimental product treated group (17±18 ppm versus 34±47 ppm) in the per protocol population. The difference between the means of the two groups was -17 ppm (95% confidence interval [95% CI]: -31.03; -3.17). The upper limit of the 95% CI did not exceed the a priori non-inferiority limit (7.5 ppm). Secondary efficacy analyses confirmed that the treatments were similar (per protocol and intention to treat population). The tolerability was excellent in both groups, and there were no reports of serious adverse events related to the study treatment., Conclusion: The experimental product was non-inferior to the reference product, indicating that it was an effective replacement therapy for endogenous lactase in lactose intolerance patients.

Context: Irritable bowel syndrome (IBS) is a functional bowel disease characterized by abdominal pain and altered intestinal habits. The pathophysiology of IBS remains unclear. Recent studies have demonstrated that some IBS patients, especially in diarrhea-predominant IBS (IBS-D), display persistent signs of minor mucosal inflammation and a modified intestinal microflora. The mesalazine has known intestinal anti-inflammatory properties. Saccharomyces boulardii is a probiotic used for a long time in treatment of diarrhea, including infectious diarrhea., Objective: Evaluate the effects of mesalazine alone, combined therapy of mesalazine with liophylised Saccharomyces boulardii or alone on symptoms of IBS-D patients., Methods: Based on Rome III criteria, 53 IBS-D patients (18 year or more) were included. To exclude organic diseases all patients underwent colonoscopy, stool culture, serum anti-endomisium antibody, lactose tolerance test and ova and parasite exam. Patients were divided in three groups: mesalazine group (MG) - 20 patients received mesalazine 800 mg t.i.d. for 30 days; mesalazine and Saccharomyces boulardii group (MSbG) - 21 patients received mesalazine 800 mg t.i.d. and Saccharomyces boulardii 200 mg t.i.d. for 30 days and; Saccharomyces boulardii group (SbG) - 12 patients received Sb 200 mg t.i.d. for 30 days. Drugs that might have any effect on intestinal motility or secretion were not allowed. Symptom evaluations at baseline and after treatment were performed by means of a 4-point likert scale including: stool frequency, stool form and consistency (Bristol scale), abdominal pain and distension. Paired t test and Kruskal-Wallis test were used for statistical analyses., Results: Compared to baseline, there were statistically significant reduction of symptom score after 30 th day therapy in all three groups: MG (P<0.0001); MSbG (P<0.0001) and in SbG (P = 0.003). There were statistically significant differences in the symptom score at 30 th day therapy of the MG, MSbG and SbG groups (P = 0.03). There were no statistical differences between MSbG and MG symptom score at 30th day therapy (P = 0.9)., Conclusions: The use of mesalazine alone, Saccharomyces boulardii alone or combined treatment with mesalasine and Saccaromyces boulardii improved IBS-D symptoms. The improvement of the symptom score was greater with mesalazine alone or combined with Sb as compared with Sb treatment alone. These preliminary results suggest that mezalazine may be useful in treatment of IBS-d patients, and warrant further larger studies.

Unlabelled: CCX282-B, also called vercirnon, is a specific, orally-administered chemokine receptor CCR9 antagonist that regulates migration and activation of inflammatory cells in the intestine. This randomized, placebo-controlled trial was conducted to evaluate the safety and efficacy of CCX282-B in 436 patients with Crohn's disease. Crohn's Disease Activity Index (CDAI) scores were 250-450 and C-reactive protein >7.5 mg/L at study entry. In addition to stable concomitant Crohn's medication (85% of subjects), subjects received placebo or CCX282-B (250 mg once daily, 250 mg twice daily, or 500 mg once daily) for 12 weeks. They then received 250 mg CCX282-B twice daily, open-label, through week 16. Subjects who had a clinical response (a ≥ 70 point drop in CDAI) at week 16 were randomly assigned to groups given placebo or CCX282-B (250 mg, twice daily) for 36 weeks. Primary endpoints were clinical response at Week 8 and sustained clinical response at Week 52. During the 12-week Induction period, the clinical response was highest in the group given 500 mg CCX282-B once daily. Response rates at week 8 were 49% in the placebo group, 52% in the group given CCX282-B 250 mg once daily (odds ratio [OR] = 1.12; p = .667 vs placebo), 48% in the group given CCX282-B 250 mg twice daily (OR = 0.95; p = .833), and 60% in the group given CCX282-B 500 mg once daily (OR = 1.53; p = .111). At week 12, response rates were 47%, 56% (OR = 1.44; p = .168), 49% (OR = 1.07; p = .792), and 61% (OR = 1.74; p = .039), respectively. At the end of the Maintenance period (week 52), 47% of subjects on CCX282-B were in remission, compared to 31% on placebo (OR = 2.01; p = .012); 46% showed sustained clinical responses, compared to 42% on placebo (OR = 1.14; p = .629). CCX282-B was well tolerated. Encouraging results from this clinical trial led to initiation of Phase 3 clinical trials in Crohn's disease., Trial Registration: ClinicalTrials.gov NCT00306215.

Context: Functional dyspepsia is a condition in which symptoms are not related to organic underlying disease; its pathogenesis is not well known. The small intestinal bacterial overgrowth (SIBO) is characterized by the increase in the number and/or type of colonic bacteria in the upper gastrointestinal tract. The hypothesis of SIBO being associated to functional dyspepsia must be considered, since the impaired motility of the gastrointestinal tract is one of the main etiologic factors involved on both pathologies., Objective: To determine if there is SIBO in patients with functional dyspepsia., Methods: Case-control study, evaluating 34 patients: 23 functional dyspeptic and 11 non-dyspeptic (control group). Questionnaire applied based on Rome III criteria. The patients underwent H2-lactulose breath test, considered positive when: H2 peak exceeding 20 ppm, in relation to fasting, or two peaks exceeding 10 ppm sustained until 60 minutes., Results: Of the 23 dyspeptic patients, 13 (56.5%) obtained positive results for SIBO trough the H2-lactulose breath test. On control group, SIBO was not observed. The association between the dyspeptic group and the control group regarding SIBO was statistically significant, with P = 0.0052. In the group of dyspeptic patients, 12 (52.2%) were using proton pump inhibitor; of these 9 (75%) were positive for SIBO. In the control group, none of the 11 patients used proton pump inhibitors and SIBO was not observed. The association of the dyspeptic group using proton pump inhibitor that were positive for SIBO and the control group was statistically significant, with P = 0.0011., Conclusion: It was found that, patients with functional dyspepsia presented SIBO, when they underwent to H2-lactulose breath test, compared to the non-dyspeptic. In addition, it was observed a higher prevalence of SIBO in dyspeptic patients that were using proton pump inhibitors, compared to control group.

Context: Recent studies support the hypothesis that postinfectious irritable bowel syndrome and some irritable bowel syndrome patients display persistent signs of minor mucosal inflammation. Mesalazine has intestinal anti-inflammatory properties including cyclooxygenase and prostaglandin inhibition. The effects of mesalazine on postinfectious irritable bowel syndrome and noninfective irritable bowel syndrome patients are still unknown., Objective: To observe the effects of mesalazine on postinfectious irritable bowel syndrome and noninfective irritable bowel syndrome with diarrhea patients., Methods: Based on Rome III criteria, 61 irritable bowel syndrome with diarrhea patients (18 years old or more) were included in the evaluation. Patients were divided into two groups: postinfectious irritable bowel syndrome group, with 18 patients medicated with mesalazine 800 mg 3 times a day for 30 days; noninfective irritable bowel syndrome group, with 43 patients medicated with mesalazine 800 mg 3 times a day for 30 days. Symptom evaluations at baseline and after treatment were performed by means of a four-point Likert scale including stool frequency, stool form and consistency (Bristol Stool Scale), abdominal pain and distension (maximum score: 16; minimum score: 4)., Results: Postinfectious irritable bowel syndrome group presented a statistically significant reduction of the total symptom score (P<0.0001). The stool frequency was significantly reduced (P<0.0001), and stool consistency, improved (P<0.0001). Abdominal pain (P<0.0001) and abdominal distension were significantly reduced (P<0.0001). Noninfective irritable bowel syndrome group presented a statistically significant reduction of total symptom score (P<0.0001). Also, the stool frequency was significantly reduced (P<0.0001) and stool consistency, improved (P<0.0001). Abdominal pain (P<0.0001) and abdominal distention were significantly reduced (P<0.0001). There was no statistical difference between postinfectious irritable bowel syndrome group and noninfective irritable bowel syndrome group on total symptom score results at 30th day of therapy with mesalazine 800 mg 3 times a day. (P = 0.13)., Conclusion: Mesalazine reduced key symptoms of postinfectious irritable bowel syndrome and noninfective irritable bowel syndrome with diarrhea patients.

The technique of laparoscopic antegrade sphincterotomy is described. This procedure was used to clear the common bile duct in 22 selected patients with documented choledocholithiasis. Indications for attempting laparoscopic antegrade sphincterotomy included multiple common bile duct stones, one or more common hepatic or intrahepatic stones, a dilated common bile duct requiring a drainage procedure, and suspicion of papillary stenosis. No major complications or mortality was observed. Mild hyperamylasemia was observed in two patients. However, both were asymptomatic, and serum amylase levels rapidly returned to normal. One patient was noted to have a drop in her hematocrit from a preoperative value of 39% to a postoperative value of 33%. Laparoscopic antegrade sphincterotomy added a mean of 17 min to the operative procedure. The mean postoperative stay was 1.4 days. The results of this study suggest that laparoscopic antegrade sphincterotomy may prove to be a useful modality in selected patients with complicated choledocholithiasis.

The clinical and pathological manifestations of a case of carcinosarcoma of the esophagus are reported. Barium swallow and endoscopy revealed a polypoid mass in mid esophagus. The tumor was large, pedunculated, covered by smooth mucosa with some erosions. Histologically the tumor was composed of a mixture of invasion keratinizing cells and intermingled bundle of spindle shaped cells resembling fibrosarcoma. The tumor was removed with surgery and did not show submucosa infiltration. It was not detected any metastasis or local recurrence during the 12 months follow-up period. The diagnosis was made by an endoscopic partial polypectomy. We conclude that partial polypectomy may be of value in preoperative diagnosis of esophageal polypoid mass.