Psyllium in Pediatric IBS
ConditionIrritable Bowel Syndrome
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Psyllium (0.7 g/year of age per day)
DrugPsyllium (0.7 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)
Psyllium (0.5 g/year of age per day)
DrugPsyllium (0.5 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)
Placebo
DrugPlacebo (0.7 g/year of age glucose) (Staleydex 333; Tate \& Lyle, Staley, London, UK)
fructans
Other interventionDaily dose 0.5 g/kg up to 19 grams, Orafti Synergy1
Treatment groups
110 Participants
are divided into 3 treatment groupsGroup A: Psyllium (0.7 g/year of age per day) given with fructansActive comparator 2 interventions
Group B: Psyllium (0.5 g/year of age per day) given with fructansActive comparator 2 interventions
Group C: Placebo (0.7 g/year of age glucose) given with fructansPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in microbiome composition measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing
Time frame
Baseline, 2 weeks2
Change in fecal lactate
Time frame
Baseline, 2 weeks3
Change in fecal short-chain fatty acids
Time frame
Baseline, 2 weeks4
Change in hydrogen gas production
Time frame
Baseline, 2 weeksSecondary outcomes
1
Change in abdominal pain frequency
Time frame
Baseline, 2 weeks2
Change in abdominal pain severity
Participants will rate abdominal pain on a scale of 0-10, with higher scores indicating more severe pain.
Time frame
Baseline, 2 weeks3
Change in bloating severity
Participants will rate bloating on a scale of 0-10, with higher scores indicating worse bloating.
Time frame
Baseline, 2 weeks4
Change in flatulence severity
Participants will rate flatulence on a scale of 0-10, with higher scores indicating worse flatulence.
Time frame
Baseline, 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr Bruno Chumpitazi, M.D.
Lead sponsor
Duke University
Sponsor institution
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov