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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 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.

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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

Irritable Bowel Syndrome

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

FieldValue
Enrollment Target 110 participants
Start Date 2025-02-20
Est. Completion 2027-04-30
Phase Phase 2

Sponsor

Dr Bruno Chumpitazi, M.D.

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06639984

The ClinicalTrials.gov registry entry for NCT06639984 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 142-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (23% lower). The listed sponsor is Dr Bruno Chumpitazi, M.D., which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.