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Recruiting Phase 2 NCT06639984

Psyllium in Pediatric IBS

Phase 2 – studying effectiveness and dosage
Conditions: Irritable Bowel Syndrome

Sponsor: Dr Bruno Chumpitazi, M.D.

trial.available_in: БГ
Overview
The goal of this clinical trial is to learn if a fiber (psyllium) can change the way bacteria use fructans (a type of sugar) and whether psyllium can help decrease childhood irritable bowel syndrome (IBS) symptoms when eating fructans. The main questions it aims to answer are: Aim 1: The effect of psyllium at two doses given with a fructan meal on microbial fructan fermentation (intracolonic pH; H2 gas production; gut microbiome composition; fecal short-chain fatty acids, lactate, glycomics). Aim 2: Determine the impact of psyllium given with a fructan meal on fructan-induced GI symptoms. Participants will first be asked to eat a specific diet over two three-day periods to determine if fructans worsen their IBS symptoms. Those with worsening symptoms with fructans will be asked to participate in the second part of the study. This includes two weeks of baseline (no change in diet) and two weeks of eating a specific diet with fructans with either psyllium or glucose. Participants will be asked to complete pain and stool diaries, submit stool specimens, swallow a pill to capture gut acid levels, and give breath samples.
Who can participate
Inclusion Criteria: * Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS Exclusion Criteria: * Children who have had previous bowel surgery, have documented GI disorders (e.g., ulcerative colitis), or a serious chronic medical condition (e.g., diabetes) * weight and/or height are \> or \< 2 SD for age * have chronic conditions with GI symptoms (e.g., cystic fibrosis) * have been on antibiotics or probiotics within 3 months (because of potential alterations to the GI microbiome0 * girls who are pregnant (tested with urine beta-human chorionic gonadotropin at the initial visit)
Interventions
Psyllium (0.7 g/year of age per day)
DRUG
Psyllium (0.5 g/year of age per day)
DRUG
Placebo
DRUG
fructans
OTHER
Locations 1
United States (1)
Duke University
Durham , North Carolina
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
20.02.2025
Completion date
30.09.2027
Registry ID
NCT06639984
Source
clinicaltrials.gov
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