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RECRUITING
NCT06639984
PHASE2

Psyllium in Pediatric IBS

Sponsor: Dr Bruno Chumpitazi, M.D.

View on ClinicalTrials.gov

Summary

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.

Official title: Assessing Psyllium Given With Meals for Fructan Sensitivity in Children With Irritable Bowel Syndrome

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2025-02-20

Completion Date

2027-04-30

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

DRUG

Psyllium (0.7 g/year of age per day)

Psyllium (0.7 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)

DRUG

Psyllium (0.5 g/year of age per day)

Psyllium (0.5 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)

DRUG

Placebo

Placebo (0.7 g/year of age glucose) (Staleydex 333; Tate \& Lyle, Staley, London, UK)

OTHER

fructans

Daily dose 0.5 g/kg up to 19 grams, Orafti Synergy1

Locations (1)

Duke University

Durham, North Carolina, United States