Back to search results

Psyllium for Irritable Bowel Syndrome in Children

This study is looking at whether psyllium, a type of fiber, can help children aged 12 to 17 who have Irritable Bowel Syndrome (IBS). Researchers want to see if psyllium can change how gut bacteria use certain sugars called fructans, and if it can reduce IBS symptoms caused by eating fructans. You might be eligible if you are 12-17 years old and meet the criteria for pediatric IBS. The study will measure changes in your gut bacteria and other markers in your stool, as well as your IBS symptoms, to see if psyllium is helpful. The current status of this study is unclear, and it plans to enroll 110 participants.

Study design
This interventional study plans to enroll 110 participants. It compares two different doses of psyllium and a placebo (an inactive substance) given with fructans.
What's involved
Participants will first follow a specific diet over two three-day periods to see if fructans worsen their IBS symptoms. The trial record does not specify further details about visits or procedures.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, such as changes in gut bacteria and fecal markers, will be measured at baseline and after 2 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06639984

Psyllium in Pediatric IBS

Recruiting
PHASE2Ages 12–17InterventionalTreatment
Dr Bruno Chumpitazi, M.D.
~110 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:Psyllium (0.7 g/year of age per day)Psyllium (0.5 g/year of age per day)Placebofructans

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in microbiome composition measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing
Measured over Baseline, 2 weeks
+4 more outcomes measured

Conditions

Irritable Bowel Syndrome

Explore related trials

Abdominal PainIrritable Bowel Syndrome

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Bruno Chumpitazi, MD, MPH · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Bruno Chumpitazi, MD, MPH
[email protected]
919-660-1227
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS

Exclusion

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)

What this trial measures

  • Change in microbiome composition measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencingBaseline, 2 weeks
  • Change in fecal lactateBaseline, 2 weeks
  • Change in fecal short-chain fatty acidsBaseline, 2 weeks
  • Change in hydrogen gas productionBaseline, 2 weeks
  • Change in fecal fructansBaseline, 2 weeks