Dataset Information

Psyllium Fiber Reduces Abdominal Pain in Children With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial.

ABSTRACT: We sought to determine the efficacy of psyllium fiber treatment on abdominal pain and stool patterns in children with irritable bowel syndrome (IBS). We evaluated effects on breath hydrogen and methane production, gut permeability, and microbiome composition. We also investigated whether psychological characteristics of children or parents affected the response to treatment.We performed a randomized, double-blind trial of 103 children (mean age, 13 ± 3 y) with IBS seen at primary or tertiary care settings. After 2 weeks on their habitual diet, children began an 8-day diet excluding carbohydrates thought to cause symptoms of IBS. Children with ?75% improvement in abdominal pain were excluded (n = 17). Children were assigned randomly to groups given psyllium (n = 37) or placebo (maltodextrin, n = 47) for 6 weeks. Two-week pain and stool diaries were compared at baseline and during the final 2 weeks of treatment. We assessed breath hydrogen and methane production, intestinal permeability, and the composition of the microbiome before and after administration of psyllium or placebo. Psychological characteristics of children were measured at baseline.Children in the psyllium group had a greater reduction in the mean number of pain episodes than children in the placebo group (mean reduction of 8.2 ± 1.2 after receiving psyllium vs mean reduction of 4.1 ± 1.3 after receiving placebo; P = .03); the level of pain intensity did not differ between the groups. Psychological characteristics were not associated with response. At the end of the study period, the percentage of stools that were normal (Bristol scale scores, 3-5), breath hydrogen or methane production, intestinal permeability, and microbiome composition were similar between groups.Psyllium fiber reduced the number of abdominal pain episodes in children with IBS, independent of psychological factors. Psyllium did not alter breath hydrogen or methane production, gut permeability, or microbiome composition. ClinicalTrials.gov no: NCT00526903.

SUBMITTER: Shulman RJ

PROVIDER: S-EPMC5064811 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Psyllium Fiber Reduces Abdominal Pain in Children With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial.

Shulman Robert J RJ Hollister Emily B EB Cain Kevin K Czyzewski Danita I DI Self Mariella M MM Weidler Erica M EM Devaraj Sridevi S Luna Ruth Ann RA Versalovic James J Heitkemper Margaret M

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 20160411 5

<h4>Background & aims</h4>We sought to determine the efficacy of psyllium fiber treatment on abdominal pain and stool patterns in children with irritable bowel syndrome (IBS). We evaluated effects on breath hydrogen and methane production, gut permeability, and microbiome composition. We also investigated whether psychological characteristics of children or parents affected the response to treatment.<h4>Methods</h4>We performed a randomized, double-blind trial of 103 children (mean age, 13 ± 3 y ...[more]

PMID: 27080737

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Project description:IntroductionIrritable bowel syndrome (IBS) is characterised by the association of abdominal chronic pain with bowel habit disorders in the absence of identifiable organic disease. This is the first reason for consultation in gastroenterology, with an estimated prevalence of 10%-15% in industrialised countries. Although this is a benign gastrointestinal disease, its chronicity profoundly impacts the patient's quality of life and causes considerable health spending. Actual medical treatments are poorly efficient on IBS-related abdominal pain, making it a major public health concern. The mechanisms causing IBS symptoms are unknown. Recent studies have shown the involvement of T-type channel in abdominal pain. We aim to evaluate the therapeutic potential of ethosuximide, a T-type channel blocker, on the abdominal pain of patients presenting an IBS.Methods and analysisThe IBSET trial is a randomised, controlled, parallel, double-blind and multicentre study. It is the first clinical trial evaluating the efficacy and safety of ethosuximide on abdominal pain related to IBS. Adults with IBS that report significant abdominal pain (?4/10) at least for 3 months will be included. 290 patients will be randomly assigned to receive either ethosuximide or placebo over 12 weeks after 1?week of run-in period. The primary endpoint is the rate of responders (pain reduction ?30%?and Subject Global Assessment of Relief score ?4). The intensity of abdominal pain will be assessed by an 11-point Numerical Rating Scale before and after 12 weeks of treatment and the score of the Subject Global Assessment of Relief scale at the end of treatment. The secondary endpoints are the safety of ethosuximide, the intensity and features of IBS and quality of life.Ethics and disseminationThe study was approved by an independent medical ethics committee (CPP Sud-Est VI, Clermont-Ferrand, France). The results will be published in a peer-review journal and presented at international congresses.Trial registration numberNCT02973542; Pre-results.

Project description:Study objectivesSleep deficiency, psychological distress, daytime dysfunction, and abdominal pain are common in adults with irritable bowel syndrome. Prior research on individuals with chronic pain has identified the indirect effect of sleep on pain through psychological distress or daytime dysfunction; however, this effect is less clear in irritable bowel syndrome. The purpose of this study was to examine potential indirect effects of sleep on abdominal pain symptoms simultaneously through psychological distress and daytime dysfunction in adults with irritable bowel syndrome.MethodsDaily symptoms of nighttime sleep complaints (sleep quality and refreshment), psychological distress, daytime dysfunction (fatigue, sleepiness, and difficulty concentrating), and abdominal pain were collected in baseline assessments from 2 randomized controlled trials of 332 adults (mean age 42 years and 85% female) with irritable bowel syndrome. Structural equation modeling was used to examine the global relationships among nighttime sleep complaints, psychological distress, daytime dysfunction, and abdominal pain.ResultsThe structural equation modeling analyses found a strong indirect effect of poor sleep on abdominal pain via daytime dysfunction but not psychological distress. More than 95% of the total effect of nighttime sleep complaints on abdominal pain was indirect.ConclusionsThese findings suggest that the primary impact of nighttime sleep complaints on abdominal pain is indirect. The indirect effect appears primarily through daytime dysfunction. Such understanding provides a potential avenue to optimize personalized and hybrid behavioral interventions for adults with irritable bowel syndrome through addressing daytime dysfunction and sleep behaviors. Additional study integrating symptoms with biological markers is warranted to explore the underlying mechanisms accounting for these symptoms.Clinical trial registrationRegistry: ClinicalTrials.gov. Name: Nursing Management of Irritable Bowel Syndrome: Improving Outcomes, Nursing Management of IBS: Improving Outcomes. URLs: https://clinicaltrials.gov/ct2/show/NCT00167635, https://clinicaltrials.gov/ct2/show/NCT00907790. Identifiers: NCT00167635, NCT00907790.

Project description:AimTo examine the efficacy and safety of otilonium bromide (OB) in treatment-sensitive functional irritable bowel syndrome (IBS) clinical parameters.MethodsNinety-three patients (44.8 ± 12.6 years, 69% female) with IBS symptoms complying with Rome II criteria participated in this double-blind, placebo-controlled, randomised, dose-ranging phase I/II study. Patients were administered OB 20 mg (n = 24), 40 mg (n = 23) and 80 mg (n = 23) tid or placebo (n = 23) in 4 parallel groups for 4 wk. Primary efficacy variables included abdominal discomfort, intestinal habits, number of daily evacuations and stool consistency. Secondary efficacy measures included return to regular intestinal habits and global discomfort. Safety was also assessed.ResultsBaseline clinical characteristics were similar among the 4 groups. Although individual parameters such as intensity and frequency of abdominal discomfort, bloating or pain were reduced by OB over the 4 wk, no significant differences were observed between groups. Similarly, no difference was observed between OB treatment or placebo for mucus in stool and incomplete or difficulty of evacuation. However, evacuation frequency was significantly reduced after 4 wk by 80 mg OB compared to placebo (-8.36% for placebo vs -41.9% for 80 mg OB, P < 0.01). While 21.7% of patients in the placebo group experienced regular intestinal habits after 4 wk, this improvement was greater for patients treated with 40 mg OB (P < 0.01 vs placebo). Furthermore, a dose-dependent reduction in frequency of diarrhoea (χ(2)-test for trend = 11.5, P < 0.001) and an increase in normal stool frequency was observed. Combining individual variables into a global discomfort index revealed significant improvement among increasing OB doses, favouring 40 mg (P = 0.013) and 80 mg OB (P = 0.001) over placebo. No difference was observed between frequency of adverse events for placebo vs OB.ConclusionThis dose-ranging study demonstrates that OB at 40 and 80 mg can improve individual and global clinical symptoms of IBS compared to placebo over a 4-wk period.

Dataset Information

Psyllium Fiber Reduces Abdominal Pain in Children With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial.

Publications

Psyllium Fiber Reduces Abdominal Pain in Children With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial.

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