Psyllium in Pediatric IBS

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-17
SponsorDr Bruno Chumpitazi, M.D.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Psyllium (0.7 g/year of age per day)
  • Psyllium (0.5 g/year of age per day)
  • Placebo
  • fructans

Treatment groups

110 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Dr Bruno Chumpitazi, M.D.

Lead sponsor

Duke University

Sponsor institution

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

Collaborator