Psyllium in Pediatric IBS
Key facts
- Where
- Durham, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 17 years old?
Source: NCT06639984, who can take part
Where in United States
- Duke UniversityDurham, United StatesContact: Annette BabuTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Dr Bruno Chumpitazi, M.D.
- Trial code
- NCT06639984
- Record updated
- 26 May 2026
- Original description
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:Read full original descriptionShow less
Assessing Psyllium Given With Meals for Fructan Sensitivity in Children With Irritable Bowel Syndrome
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.
Inclusion: Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS.
Exclusion: Children who have had previous bowel surgery, have documented GI disorders (e.g., ulcerative colitis), or a serious chronic medical condition (e.g., diabetes); have chronic conditions with GI symptoms (e.g., cystic fibrosis); weight and/or height are \> or \< 2 SD for age; 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).