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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
110
Psyllium (0.7 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)
Psyllium (0.5 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)
Placebo (0.7 g/year of age glucose) (Staleydex 333; Tate \& Lyle, Staley, London, UK)
Daily dose 0.5 g/kg up to 19 grams, Orafti Synergy1
Duke University
Durham, North Carolina, United States
RECRUITINGChange in microbiome composition measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing
Time frame: Baseline, 2 weeks
Change in fecal lactate
Time frame: Baseline, 2 weeks
Change in fecal short-chain fatty acids
Time frame: Baseline, 2 weeks
Change in hydrogen gas production
Time frame: Baseline, 2 weeks
Change in fecal fructans
Time frame: Baseline, 2 weeks
Change in abdominal pain frequency
Time frame: Baseline, 2 weeks
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 weeks
Change in bloating severity
Participants will rate bloating on a scale of 0-10, with higher scores indicating worse bloating.
Time frame: Baseline, 2 weeks
Change in flatulence severity
Participants will rate flatulence on a scale of 0-10, with higher scores indicating worse flatulence.
Time frame: Baseline, 2 weeks
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