RECRUITING

Psyllium in Pediatric IBS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-20
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06639984

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS
  1. * Children who have had previous bowel surgery, have documented GI disorders (e.g., ulcerative colitis), or a serious chronic medical condition (e.g., diabetes)
  2. * weight and/or height are \> or \< 2 SD for age
  3. * have chronic conditions with GI symptoms (e.g., cystic fibrosis)
  4. * have been on antibiotics or probiotics within 3 months (because of potential alterations to the GI microbiome0
  5. * girls who are pregnant (tested with urine beta-human chorionic gonadotropin at the initial visit)

Contacts and Locations

Study Contact

Bruno Chumpitazi, MD, MPH
CONTACT
919-681-8739
bruno.chumpitazi@duke.edu
Joan Wilson, BSN, MPH
CONTACT
919-681-8739
joan.wilson@duke.edu

Principal Investigator

Bruno Chumpitazi, MD, MPH
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Dr Bruno Chumpitazi, M.D.

  • Bruno Chumpitazi, MD, MPH, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-20
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2025-02-20
Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

  • Abdominal Pain

Additional Relevant MeSH Terms

  • Irritable Bowel Syndrome