Recruiting
Phase 2

Psyllium

Sponsor:

Dr Bruno Chumpitazi, M.D.

Code:

NCT06639984

Conditions

Irritable Bowel Syndrome

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Psyllium (0.7 g/year of age per day)

Psyllium (0.5 g/year of age per day)

Placebo

fructans

Study Details

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.

Conditions

Irritable Bowel Syndrome

Study ID

NCT06639984

Start date

Feb 20, 2025

Status verified date

May, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Psyllium (0.7 g/year of age per day) given with 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)

active comparator: Psyllium (0.5 g/year of age per day) given with 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 comparator: Placebo (0.7 g/year of age glucose) given with 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).

Interventions

Psyllium (0.7 g/year of age per day)

Psyllium (0.7 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)

Psyllium (0.5 g/year of age per day)

Psyllium (0.5 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)

Placebo

Placebo (0.7 g/year of age glucose) (Staleydex 333; Tate \& Lyle, Staley, London, UK)

fructans

Daily dose 0.5 g/kg up to 19 grams, Orafti Synergy1

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Bruno Chumpitazi, MD, MPH

919-660-1227bruno.chumpitazi@duke.edu

Annette Babu

919-660-1227annette.babu@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Annette Babu

9196601227annette.babu@duke.edu

Principal Investigator:

Bruno Chumpitazi

More Information

Sponsor

Dr Bruno Chumpitazi, M.D.

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • Abdominal Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dr Bruno Chumpitazi, M.D. on 2026-05-26.