Psyllium in Pediatric IBS

Phase 3

Recruiting

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Psyllium (0.5 g/year of age per day); Drug: Psyllium (0.7 g/year of age per day); Drug: Placebo; Other: fructans

• Registration Number: NCT06639984
• Lead Sponsor: Dr Bruno Chumpitazi, M.D.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-10-10
• Study First Posted: 2024-10-15
• Study Start: 2025-02-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2027-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psyllium (0.5 g/year of age per day) given with fructans	Psyllium (0.5 g/year of age per day)	Participants will receive Psyllium (0.5 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams)
Psyllium (0.7 g/year of age per day) given with fructans	Psyllium (0.7 g/year of age per day)	Participants will receive Psyllium (0.7 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams)
Psyllium (0.7 g/year of age per day) given with fructans	fructans	Participants will receive Psyllium (0.7 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams)
Psyllium (0.5 g/year of age per day) given with fructans	fructans	Participants will receive Psyllium (0.5 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams)
Placebo (0.7 g/year of age glucose) given with fructans	Placebo	Participants will receive Placebo (0.7 g/year of age glucose) given with fructans (daily dose 0.5 g/kg up to 19 grams).
Placebo (0.7 g/year of age glucose) given with fructans	fructans	Participants will receive Placebo (0.7 g/year of age glucose) given with fructans (daily dose 0.5 g/kg up to 19 grams).

Primary Outcome Measures

Name	Time	Method
Change in fecal lactate	Baseline, 2 weeks
Change in fecal short-chain fatty acids	Baseline, 2 weeks
Change in hydrogen gas production	Baseline, 2 weeks
Change in fecal fructans	Baseline, 2 weeks
Change in microbiome composition measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing	Baseline, 2 weeks

Secondary Outcome Measures

Name	Time	Method
Change in abdominal pain frequency	Baseline, 2 weeks
Change in abdominal pain severity	Baseline, 2 weeks	Participants will rate abdominal pain on a scale of 0-10, with higher scores indicating more severe pain.
Change in bloating severity	Baseline, 2 weeks	Participants will rate bloating on a scale of 0-10, with higher scores indicating worse bloating.
Change in flatulence severity	Baseline, 2 weeks	Participants will rate flatulence on a scale of 0-10, with higher scores indicating worse flatulence.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States