| NCT ID | NCT06639984 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Dr Bruno Chumpitazi, M.D. |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 110 participants in total. It began in 2025-02-20 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS Exclusion Criteria: * Children who have had previous bowel surgery, have documented GI disorders (e.g., ulcerative colitis), or a serious chronic medical condition (e.g., diabetes) * weight and/or height are \> or \< 2 SD for age * have chronic conditions with GI symptoms (e.g., cystic fibrosis) * 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)
Contact & Investigator
Bruno Chumpitazi, MD, MPH
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06639984 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06639984 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06639984 currently recruiting?
Yes, NCT06639984 is actively recruiting participants. Contact the research team at bruno.chumpitazi@duke.edu for enrollment information.
Where is the NCT06639984 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06639984 clinical trial?
NCT06639984 is sponsored by Dr Bruno Chumpitazi, M.D.. The principal investigator is Bruno Chumpitazi, MD, MPH at Duke University. The trial plans to enroll 110 participants.