Psyllium in Pediatric IBS

NCT06639984 — Phase 2, Recruiting, 110 participants, Dr Bruno Chumpitazi, M.D.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT06639984, acronym Psyllium
Status	Recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	110 (Estimated)
Sponsor	Dr Bruno Chumpitazi, M.D. (Other); collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions	Irritable Bowel Syndrome
Interventions	Psyllium (0.7 g/year of age per day), Psyllium (0.5 g/year of age per day), Placebo, fructans (Drug, other)
Dates	start 2025-02-20, primary completion 2027-09-30 (estimated), completion 2027-09-30 (estimated), first posted 2024-10-15, last updated 2026-05-26
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Psyllium (0.7 g/year of age per day) given with fructans	Active comparator	Drug: Psyllium (0.7 g/year of age per day); Other: 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	Active comparator	Drug: Psyllium (0.5 g/year of age per day); Other: 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 comparator	Drug: Placebo; Other: 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).

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

+Outcome measures

Primary outcomes

Change in microbiome composition measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing [Baseline, 2 weeks]
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]

Secondary outcomes

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.

+Eligibility

Sex: All, ages: 12 Years to 17 Years

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 \&gt; or \&lt; 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)

+Locations (1)

Facility	City	Country	Status
Duke University	Durham, North Carolina	United States	Recruiting

+Investigators

Bruno Chumpitazi, MD, MPH, Principal investigator, Duke University