Actively Recruiting
Psyllium in Pediatric IBS
Led by Dr Bruno Chumpitazi, M.D. · Updated on 2026-04-23
110
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
Sponsors
D
Dr Bruno Chumpitazi, M.D.
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Psyllium in Pediatric IBS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS
You will not qualify if you...
- Children who have had previous bowel surgery, have documented gastrointestinal disorders such as ulcerative colitis, or serious chronic medical conditions like diabetes
- Weight and/or height more than 2 standard deviations above or below the average for their age
- Children with chronic conditions causing gastrointestinal symptoms, such as cystic fibrosis
- Use of antibiotics or probiotics within 3 months prior to the study
- Girls who are pregnant (confirmed by urine beta-human chorionic gonadotropin at the initial visit)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
Research Team
B
Bruno Chumpitazi, MD, MPH
CONTACT
A
Annette Babu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here