Trial · NCT06639984
Psyllium in Pediatric IBS
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 decre
- Status
- Recruiting
- Sponsor
- Dr Bruno Chumpitazi, M.D.
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 110 participants (planned)
- Start
- Feb 20, 2025
- Primary completion
- Sep 30, 2027
- Conditions
- Irritable Bowel Syndrome
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.
Interventions
- Psyllium (0.7 g/year of age per day) Drug
- Psyllium (0.5 g/year of age per day) Drug
- Placebo Drug
- fructans Other
Locations
1 country: United States.
| Facility | City | Country |
|---|---|---|
| Duke University | Durham, North Carolina | United States |
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Listing only. Eligibility is decided by the study team. TreatIBS is not involved in recruitment.