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Psyllium in Pediatric IBS

NCT06639984 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-04-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Dr Bruno Chumpitazi, M.D.

    lead OTHER

Principal Investigators

  • Bruno Chumpitazi, MD, MPH · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06639984 on ClinicalTrials.gov