Psyllium in Pediatric IBS

NCT06639984 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Pro00114630
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

Abdominal Pain

Outcome Measures

Primary Outcomes (5)

• 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 (4)

• Change in abdominal pain frequency

  Baseline, 2 weeks

• Change in abdominal pain severity

  Baseline, 2 weeks

• Change in bloating severity

  Baseline, 2 weeks

• Change in flatulence severity

  Baseline, 2 weeks

Study Arms (3)

Psyllium (0.7 g/year of age per day) given with fructans

ACTIVE COMPARATOR

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)

Drug: Psyllium (0.7 g/year of age per day); Other: fructans

Psyllium (0.5 g/year of age per day) given with fructans

ACTIVE COMPARATOR

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)

Drug: Psyllium (0.5 g/year of age per day); Other: fructans

Placebo (0.7 g/year of age glucose) given with fructans

PLACEBO COMPARATOR

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

Drug: Placebo; Other: fructans

Interventions

Psyllium (0.7 g/year of age per day) DRUG

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

Psyllium (0.7 g/year of age per day) given with fructans

Psyllium (0.5 g/year of age per day) DRUG

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

Psyllium (0.5 g/year of age per day) given with fructans

Placebo DRUG

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

Placebo (0.7 g/year of age glucose) given with fructans

fructans OTHER

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

Placebo (0.7 g/year of age glucose) given with fructans; Psyllium (0.5 g/year of age per day) given with fructans; Psyllium (0.7 g/year of age per day) given with fructans

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr Bruno Chumpitazi, M.D.: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Interventions

Psyllium; Fructans

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Polysaccharides; Carbohydrates

Study Officials

• Bruno Chumpitazi, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Chumpitazi, MD, MPH

CONTACT

919-681-8739; bruno.chumpitazi@duke.edu

Annette Babu

CONTACT

annette.babu@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor Temporary in the Department of Pediatrics, Pediatrics, Gastroenterology, Hepatology and Nutrition

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 15, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)