Treatment of postinfectious irritable bowel syndrome and noninfective irritable bowel syndrome with mesalazine

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.

Download Full-text

Efficacy and mode of action of mesalazine in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D): a multicentre, parallel-group, randomised placebo-controlled trial

Efficacy and Mechanism Evaluation ◽

10.3310/eme02020 ◽

2015 ◽

Vol 2 (2) ◽

pp. 1-62 ◽

Cited By ~ 3

Author(s):

Ching Lam ◽

Wei Tan ◽

Matthew Leighton ◽

Margaret Hastings ◽

Melanie Lingaya ◽

...

Keyword(s):

Irritable Bowel Syndrome ◽

Abdominal Pain ◽

Controlled Trial ◽

Group Analysis ◽

Underlying Disease ◽

Stool Frequency ◽

Stool Consistency ◽

Research Network ◽

Double Blind ◽

Irritable Bowel

BackgroundDiarrhoea-predominant irritable bowel syndrome (IBS-D) is a common outcome after inflammation due to bacterial gastroenteritis. Several studies have shown ongoing immune activation in the mucosa of patients with IBS-D and a number of studies have suggested that mesalazine slow-release granule formulation (2 g; PENTASA®, Ferring Pharmaceuticals Ltd) may provide benefit including a reduction in stool frequency.ObjectivesOur primary aim was to compare the effect of mesalazine with placebo on stool frequency. Our secondary aims were to assess the effect of mesalazine on abdominal pain, stool consistency, urgency and satisfactory relief of irritable bowel syndrome (IBS) symptoms.Design/participants/interventionWe performed a double-blind, randomised placebo-controlled trial of 2 g mesalazine twice daily compared with placebo for 3 months in Rome III criteria patients with IBS-D.SettingsParticipants were recruited from the primary care research network and secondary care hospitals. Participants were randomised after a 2-week baseline stool diary. All participants completed a 12-week stool diary and at the end of each week recorded the presence of ‘satisfactory relief of IBS symptoms’. Those recruited in Nottingham had sigmoid biopsies and/or magnetic resonance imaging of the abdomen at the start and end of the trial.ResultsA total of 136 patients with IBS-D (82 female, 54 male) were randomised; 10 patients withdrew from each group. Analysis by intention to treat showed that the mean daily average stool frequency during weeks 11 and 12 was 2.8 [standard deviation (SD) 1.2] in the mesalazine group and 2.7 (SD 1.9) in the placebo group, with a group difference of 0.1 (95% confidence interval –0.33 to 0.53);p = 0.66.ConclusionsMesalazine did not improve abdominal pain, stool consistency or percentage with satisfactory relief compared with placebo during the last 2 weeks’ follow-up. A post hoc analysis in 13 postinfectious patients with IBS appeared to show benefit but this needs confirmation in a larger group. More precise subtyping based on underlying disease mechanisms may allow more effective targeting of treatment in IBS.Trial registrationCurrent Controlled Trials ISRCTN76612274.FundingThis project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and NIHR partnership.

Download Full-text

Bloating Is More Strongly Associated with Abdominal Pain Than with Stool Frequency in Irritable Bowel Syndrome with Constipation (IBS-C)

The American Journal of Gastroenterology ◽

10.14309/00000434-200509001-00938 ◽

2005 ◽

Vol 100 ◽

pp. S343

Author(s):

D. Earnest ◽

C. Dunger-Baldauf ◽

M. Shetzline

Keyword(s):

Irritable Bowel Syndrome ◽

Abdominal Pain ◽

Stool Frequency ◽

Irritable Bowel

Download Full-text

Stool Consistency And Abdominal Pain In Irritable Bowel Syndrome May Be Improved By Partially Hydrolysed Guar Gum

Journal of Pediatric Gastroenterology and Nutrition ◽

10.1097/mpg.0b013e3182307c7a ◽

2011 ◽

pp. 1 ◽

Cited By ~ 2

Author(s):

Siba Prosad Paul ◽

Penny Barnard ◽

Sujata Edate ◽

David C.A. Candy

Keyword(s):

Irritable Bowel Syndrome ◽

Abdominal Pain ◽

Guar Gum ◽

Stool Consistency ◽

Irritable Bowel

Download Full-text

A Low-FODMAP Diet Improves the Global Symptoms and Bowel Habits of Adult IBS Patients: A Systematic Review and Meta-Analysis

Frontiers in Nutrition ◽

10.3389/fnut.2021.683191 ◽

2021 ◽

Vol 8 ◽

Author(s):

Jinsheng Wang ◽

Pengcheng Yang ◽

Lei Zhang ◽

Xiaohua Hou

Keyword(s):

Systematic Review ◽

Irritable Bowel Syndrome ◽

Meta Analysis ◽

Risk Of Bias ◽

Stool Frequency ◽

Stool Consistency ◽

Controlled Trials ◽

Irritable Bowel ◽

Fodmap Diet

Background: A low-fermentable oligo-, di-, monosaccharides, and polyols (FODMAP) diet has been reported to be associated with improving the symptoms of irritable bowel syndrome (IBS); however, its efficacy as evaluated by different studies remains controversial.Objective: A systematic review and meta-analysis of randomized controlled trials (RCTs) were conducted to explore the efficacy of a low-FODMAP diet (LFD) in alleviating the symptoms of IBS.Methods: A search of the literature for RCTs that assessed the efficacy of an LFD in treating IBS patients was conducted using the electronic databases PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science. The searches in each database were conducted from the inception of the database to February 2021. Two independent reviewers screened citations and a third reviewer resolved disagreements. Two independent reviewers also performed eligibility assessments and data extraction. The RCTs that evaluated LFDs vs. a normal IBS or usual diet and assessed changes of IBS symptoms were included in the search. Data were synthesized as the relative risk of global symptoms improvement, mean difference of IBS Severity Scoring System (IBS-SSS) score, sub-items of IBS-SSS irritable bowel syndrome-related quality of life (IBS-QOL), hospital anxiety and depression scale (HADS), stool consistency/frequency, and body mass index (BMI) using a random effects model. The risk of bias was assessed using Risk of Bias Tool 2 (RoB 2). The bias of publication was assessed based on Egger's regression analysis. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology.Results: A total of 2,768 citations were identified. After full-text screening, a total of 10 studies were eligible for the systematic review and were subsequently used to compare an LFD with various control interventions in 511 participants. An LFD was associated with the improvement of global symptoms [n = 420; Risk Ratio (RR) = 1.54; 95% Confidence Interval (CI) 1.18 to 2; I2 = 38%], improvement of stool consistency [n = 434; Mean difference (MD) = −0.25; 95% CI −0.44 to −0.06; I2= 19%), and a reduction trend of stool frequency (n = 434; MD = −0.28; 95% CI −0.57 to 0.01; I2 = 68%) compared with control interventions. There was no statistically significant change in IBS-QOL (n = 484; MD = 2.77; 95% CI −2 to 7.55; I2 = 62%), anxiety score (n = 150; MD = −0.45; 95% CI −3.38 to 2.49; I2 = 86%), depression score (n = 150; MD = −0.05; 95% CI −2.5 to 2.4; I2 = 88%), and BMI (n = 110; MD = −0.22; 95% CI −1.89 to 1.45; I2 = 14%). The overall quality of the data was “moderate” for “global improvement of IBS symptom,” “stool consistency,” “stool consistency for IBS with diarrhea (IBS-D),” and “stool frequency for IBS-D,” and “low” or “very low” for other outcomes according to GRADE criteria.Conclusion: An LFD is effective in reducing the global symptoms and improving the bowel habits of adult IBS patients. The efficacy for IBS-D patients can also be more pronounced.Systematic Review Registration: CRD42021235843.

Download Full-text

A6 EFFECTS OF ELUXADOLINE TREATMENT ON ABDOMINAL AND BOWEL SYMPTOMS IN PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH DIARRHEA REPORTING INADEQUATE SYMPTOM CONTROL WITH LOPERAMIDE: AGGREGATED RESULTS FROM PHASE 3 AND 4 CLINICAL TRIALS

Journal of the Canadian Association of Gastroenterology ◽

10.1093/jcag/gwz047.005 ◽

2020 ◽

Vol 3 (Supplement_1) ◽

pp. 8-9

Author(s):

D M Brenner ◽

G Sayuk ◽

M Saeed ◽

P Janiszewski ◽

L W Liu

Keyword(s):

Irritable Bowel Syndrome ◽

Abdominal Pain ◽

Opioid Receptor ◽

Symptom Relief ◽

Symptom Control ◽

Stool Consistency ◽

Phase 3 ◽

Two Phase ◽

Wide Range ◽

Irritable Bowel

Abstract Background The heterogeneous nature of irritable bowel syndrome with diarrhea (IBS-D) presents a complex challenge in the management of a wide range of symptoms. Despite the need for more effective treatments that provide global IBS-D symptom relief, many therapies currently available in Canada only treat individual IBS-D symptoms. Eluxadoline (ELX) is a mixed µ- and κ-opioid receptor agonist and δ-opioid receptor antagonist approved by Health Canada for the treatment of IBS-D in adults. Aims To analyze the efficacy of ELX for managing a constellation of IBS-D symptoms among patients (pts) self-reporting inadequate responses to loperamide (LOP) from Phase 3 and 4 trials of ELX. Methods Adults with IBS-D were randomized to placebo (PBO) or ELX (75 or 100 mg) twice daily (BID) for 26 or 52 weeks in two Phase 3 trials (NCT01553591 and NCT01553747); the data from a subset reporting inadequate IBS-D symptom control with prior LOP use were pooled and prospectively analyzed. In the Phase 4 trial (RELIEF: NCT02959983), IBS-D pts with self-reported inadequate symptom control with LOP over the previous 12 months were randomized to PBO or ELX 100 mg BID for 12 weeks. In all trials, pts recorded their daily IBS-D symptoms including worst abdominal pain (0–10 scale), stool consistency (Bristol Stool Form Scale score 1–7), and daily urgency episodes. Results for ELX 100 mg vs. PBO were evaluated after 12 weeks of treatment, which included the generation of radar plots to visualize multiple efficacy endpoints. Results Of pts enrolled in the Phase 3 trials with prior LOP use, inadequate control of IBS-D symptoms was reported in 58.9% (n=166) and 58.8% (n=174) of pts in the PBO and ELX groups, respectively; in the Phase 4 trial, 174 and 172 pts were treated with PBO and ELX, respectively. ELX-treated pts had a greater proportion of responders compared to PBO-treated pts for all outcomes, including a significant increase in the proportion of pts achieving both ≥50% and ≥75% urgency-free days in the Phase 3 trials (Figure). Analysis of the global symptoms of pts enrolled in the Phase 4 trial further supported these results. Across Phase 3 and 4 trials, adverse events occurred in similar proportions regardless of treatment, with the most common being nausea. Conclusions In pts with inadequate responses to LOP, a greater proportion of ELX-treated pts were responders compared to PBO-treated pts in all Phase 3 and 4 trials for the respective primary composite endpoints, abdominal pain, stool consistency, and urgency after 12 weeks of treatment. These results validate the effectiveness of ELX in alleviating IBS-D symptoms in this population. Funding Agencies Writing assistance by Complete HealthVizion, funded by Allergan plc

Download Full-text

The effect of faecal microbiota transplantation on abdominal pain, stool frequency, and stool form in patients with moderate-to-severe irritable bowel syndrome: results from a randomised, double-blind, placebo-controlled study

Scandinavian Journal of Gastroenterology ◽

10.1080/00365521.2021.1915375 ◽

2021 ◽

pp. 1-9

Author(s):

Anna Maria Alcasid Madsen ◽

Sofie Ingdam Halkjær ◽

Alice Højer Christensen ◽

Stig Günther ◽

Patrick Denis Browne ◽

...

Keyword(s):

Irritable Bowel Syndrome ◽

Abdominal Pain ◽

Stool Frequency ◽

Controlled Study ◽

Faecal Microbiota ◽

Double Blind ◽

Double Blind Placebo ◽

Faecal Microbiota Transplantation ◽

Stool Form ◽

Irritable Bowel

Download Full-text

Randomised, double-blind, placebo controlled multi-centre study to assess the efficacy, tolerability and safety of Enterosgel® in the treatment of Irritable Bowel Syndrome with Diarrhoea (IBS-D) in adults

10.21203/rs.2.12205/v1 ◽

2019 ◽

Author(s):

Anu Kemppinen ◽

Carol Howell ◽

Victoria Allgar ◽

Matthew Dodd ◽

John Gregson ◽

...

Keyword(s):

Irritable Bowel Syndrome ◽

Abdominal Pain ◽

Stool Consistency ◽

Open Label ◽

Double Blind ◽

Multi Centre Study ◽

Double Blind Placebo ◽

Centre Study ◽

Irritable Bowel ◽

Drug Free

Abstract Background Irritable Bowel Syndrome (IBS) with diarrhoea (IBS-D) is a common and chronic condition that can significantly impair quality of life. The emergence of new drugs for IBS-D has been slow and there is a need for new treatments, including drug-free treatments, which are easy to use and suitable for different patient groups. Currently available drug-free treatments include Enterosgel®, an intestinal adsorbent approved for use in IBS-D and acute diarrhoea and available over-the-counter in the UK and 30 countries worldwide. The aim of this randomised, double-blind, placebo-controlled multi-centre study is to test the efficacy and safety of Enterosgel® compared to placebo in symptomatic treatment in IBS-D. Methods and design 430 participants with IBS-D will be recruited from approximately 30 primary and secondary care sites in England. Participants meeting the required abdominal pain and stool consistency criteria over a 2-week screening period, will be randomly allocated to receive blinded treatment (Enterosgel® or placebo) for 8 weeks. This will be followed by an 8-week open-label treatment phase with Enterosgel®. Participants will be allowed to adjust their daily dosage during both phases based on their symptoms. Participants will then return to standard care and those who responded to treatment will receive a follow-up call 8 weeks later. Co-medication with loperamide will be permitted and use recorded. The primary outcome measure is the percentage of participants defined as responders for abdominal pain and stool consistency during at least 4 weeks in the 8-week blinded phase. Secondary outcome measures include stool frequency, stool consistency, abdominal pain, bloating, urgency, adequate relief, questionnaire scores and rescue medication use. Exploratory outcomes will be assessed in subsets of participants including qualitative and quantitative data on faecal microorganisms and biomarkers, and gut-related measurements from magnetic resonance imaging data. Discussion This is the first large scale randomised controlled trial investigating Enterosgel® in IBS-D. A study design with blinded phase followed by an open-label phase was chosen to encourage participation and study completion. Demonstrating that Enterosgel® is effective and safe in IBS-D could encourage adoption by patients and healthcare professionals and foster future clinical trials assessing its use in related conditions.

Download Full-text