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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS

Locations
United States
North Carolina
Duke University
RECRUITING
Durham
Contact Information
Primary
Bruno Chumpitazi, MD, MPH
bruno.chumpitazi@duke.edu
919-681-8739
Backup
Joan Wilson, BSN, MPH
joan.wilson@duke.edu
919-681-8739
Time Frame
Start Date: 2025-02-20
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 110
Treatments
Active_comparator: Psyllium (0.7 g/year of age per day) given with fructans
Participants will receive Psyllium (0.7 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams)
Active_comparator: Psyllium (0.5 g/year of age per day) given with fructans
Participants will receive Psyllium (0.5 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams)
Placebo_comparator: Placebo (0.7 g/year of age glucose) given with fructans
Participants will receive Placebo (0.7 g/year of age glucose) given with fructans (daily dose 0.5 g/kg up to 19 grams).
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Dr Bruno Chumpitazi, M.D.

This content was sourced from clinicaltrials.gov