NCT06639984

Psyllium in Pediatric IBS

Assessing Psyllium Given With Meals for Fructan Sensitivity in Children With Irritable Bowel Syndrome

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Dr Bruno Chumpitazi, M.D. · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Psyllium (0.7 g/year of age per day)	Psyllium (0.7 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)
DRUG	Psyllium (0.5 g/year of age per day)	Psyllium (0.5 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)
DRUG	Placebo	Placebo (0.7 g/year of age glucose) (Staleydex 333; Tate \& Lyle, Staley, London, UK)
OTHER	fructans	Daily dose 0.5 g/kg up to 19 grams, Orafti Synergy1

Timeline

• Start date: 2025-02-20
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2024-10-15
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study