Psyllium in Pediatric IBS

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Dr Bruno Chumpitazi, M.D.
Study ID
NCT06639984
Phase
PHASE2
Status
Recruiting
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Conditions

  • Irritable Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Psyllium (0.7 g/year of age per day) — DRUG
    Psyllium (0.7 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)
  • Psyllium (0.5 g/year of age per day) — DRUG
    Psyllium (0.5 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)
  • Placebo — DRUG
    Placebo (0.7 g/year of age glucose) (Staleydex 333; Tate \& Lyle, Staley, London, UK)
  • fructans — OTHER
    Daily dose 0.5 g/kg up to 19 grams, Orafti Synergy1

Study Details

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.

Key Dates

Start date
Feb 20, 2025
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Psyllium (0.7 g/year of age per day) given with fructans
    Participants will receive Psyllium (0.7 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams)
  • Active Comparator: Psyllium (0.5 g/year of age per day) given with fructans
    Participants will receive Psyllium (0.5 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams)
  • Placebo Comparator: Placebo (0.7 g/year of age glucose) given with fructans
    Participants will receive Placebo (0.7 g/year of age glucose) given with fructans (daily dose 0.5 g/kg up to 19 grams).

Primary Outcome Measure

Change in microbiome composition measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing [ Time Frame: Baseline, 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27705
Annette Babu
[email protected]
9196601227
Bruno Chumpitazi (PRINCIPAL_INVESTIGATOR)

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By research site
Duke University· Durham, NC

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