Actively Recruiting

Phase 2
Age: 12Years - 17Years
All Genders
NCT06639984

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

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Duke University

Durham, North Carolina, United States, 27705

Actively Recruiting

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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

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