Psyllium in Pediatric IBS (NCT06639984)
Assessing Psyllium Given With Meals for Fructan Sensitivity in Children With Irritable Bowel Syndrome
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Duke University — Durham, North Carolina
Age range: 12 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Duke University — Durham, North Carolina
📞 Contact the Study Coordinator
Phone: (919) 660-1227
Email: bruno.chumpitazi@duke.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Irritable Bowel Syndrome
- Assessment of Psilocybin (TRP-8802) in Concert With Psychotherapy in Patients With Irritable Bowel Syndrome (IBS) — Boston, Massachusetts
- Pilot Study of the Physiological Effects of an Integrative Medicine Approach in Irritable Bowel Syndrome — Philadelphia, Pennsylvania
- A Well-Being Intervention for People With IBS — Madison, Wisconsin
- Standardized Yoga & Meditation Program for Stress Reduction for Adolescents With Irritable Bowel Syndrome — Camden, New Jersey
- Defining Objective Markers of Compliance for Dietary Therapies in IBS — Ann Arbor, Michigan
- Mucosal and Microbiota Changes During Acute Campylobacteriosis — Rochester, Minnesota
Explore by condition: All Irritable Bowel Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.