Irritable Bowel Syndrome
Conditions
Keywords
Abdominal Pain
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.
Interventions
DRUGPsyllium (0.7 g/year of age per day)
Psyllium (0.7 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)
DRUGPsyllium (0.5 g/year of age per day)
Psyllium (0.5 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)
DRUGPlacebo
Placebo (0.7 g/year of age glucose) (Staleydex 333; Tate \& Lyle, Staley, London, UK)
OTHERfructans
Daily dose 0.5 g/kg up to 19 grams, Orafti Synergy1
Sponsors
Dr Bruno Chumpitazi, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in abdominal pain frequency | Baseline, 2 weeks | — |
| Change in abdominal pain severity | Baseline, 2 weeks | Participants will rate abdominal pain on a scale of 0-10, with higher scores indicating more severe pain. |
| Change in bloating severity | Baseline, 2 weeks | Participants will rate bloating on a scale of 0-10, with higher scores indicating worse bloating. |
| Change in flatulence severity | Baseline, 2 weeks | Participants will rate flatulence on a scale of 0-10, with higher scores indicating worse flatulence. |
Countries
United States
Contacts
CONTACTBruno Chumpitazi, MD, MPH
CONTACTAnnette Babu
PRINCIPAL_INVESTIGATORBruno Chumpitazi, MD, MPH
Duke University
Outcome results
None listed