Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06639984

Psyllium in Pediatric IBS

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Irritable Bowel Syndrome Abdominal Pain Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke University

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Annette Babu

CONTACT

[email protected]

9196601227

Bruno Chumpitazi

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Change in microbiome composition measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing

    Time frame: Baseline, 2 weeks

  2. Change in fecal lactate

    Time frame: Baseline, 2 weeks

  3. Change in fecal short-chain fatty acids

    Time frame: Baseline, 2 weeks

  4. Change in hydrogen gas production

    Time frame: Baseline, 2 weeks

  5. Change in fecal fructans

    Time frame: Baseline, 2 weeks

Secondary outcomes

  1. Change in abdominal pain frequency

    Time frame: Baseline, 2 weeks

  2. Change in abdominal pain severity

    Time frame: Baseline, 2 weeks

    Participants will rate abdominal pain on a scale of 0-10, with higher scores indicating more severe pain.

  3. Change in bloating severity

    Time frame: Baseline, 2 weeks

    Participants will rate bloating on a scale of 0-10, with higher scores indicating worse bloating.

  4. Change in flatulence severity

    Time frame: Baseline, 2 weeks

    Participants will rate flatulence on a scale of 0-10, with higher scores indicating worse flatulence.

Study contacts

Contact information is provided by the study sponsor or research team.

Annette Babu

CONTACT

[email protected]

919-660-1227

Bruno Chumpitazi, MD, MPH

CONTACT

[email protected]

919-660-1227

Sponsors and collaborators

Lead sponsor

Dr Bruno Chumpitazi, M.D.

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Psyllium

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.