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NCT06639984 · ClinicalTrials.gov registry record · Phase 2
Psyllium in Pediatric IBS
A Phase 2 study of Irritable Bowel Syndrome, sponsored by Dr Bruno Chumpitazi, M.D..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT06639984: Recruiting Phase 2 study of Irritable Bowel Syndrome, sponsored by Dr Bruno Chumpitazi, M.D..
NCT06639984 is a Phase 2 study of Irritable Bowel Syndrome that is actively recruiting participants, run by Dr Bruno Chumpitazi, M.D.. The registered enrollment target is 110 participants, below the 142-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (23% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06639984, a Phase 2 study of Irritable Bowel Syndrome, is actively recruiting participants, sponsored by Dr Bruno Chumpitazi, M.D..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Psyllium (0.7 g/year of age per day)
- DRUG Psyllium (0.5 g/year of age per day)
- OTHER fructans
Study Locations (1)
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2025-02-20 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 2 |
What NCT06639984 shows while recruiting
NCT06639984 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 142-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (23% lower).
The record links to 1 condition, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06639984 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06639984 about?
NCT06639984 is a clinical study titled "Psyllium in Pediatric IBS". 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 ...
What is the current status of trial NCT06639984?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2025-02-20. Estimated completion is 2027-04-30.
What conditions does trial NCT06639984 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome.
What interventions are being tested in trial NCT06639984?
The interventions under investigation include: Placebo (DRUG), Psyllium (0.7 g/year of age per day) (DRUG), Psyllium (0.5 g/year of age per day) (DRUG), fructans (OTHER).
Who is sponsoring clinical trial NCT06639984?
This trial is sponsored by Dr Bruno Chumpitazi, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06639984 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06639984's enrollment target sits among peer trials
110 20th of 47 higher than 28 of 47 other Irritable Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Irritable Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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