Irritable Bowel Syndrome study: Psyllium
Official title Psyllium in Pediatric IBS
ClinicalTrials.gov ID: NCT06639984
What this study is testing
What is Psyllium (0.7 g/year of age per day)?
An investigational fiber supplement being studied for childhood irritable bowel syndrome.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if psyllium changes how gut bacteria break down fructans and if it can lessen IBS symptoms in kids who react to fructans.
- Who it's for
- Children with irritable bowel syndrome who notice their symptoms get worse after eating foods that contain fructans.
- What's involved
- Participants will follow a special diet for a few days, keep a pain and stool diary, give stool samples, swallow a pill that measures gut acid, and provide breath samples. They will then try a two‑week period with a diet that includes fructans plus either psyllium or a placebo (glucose).
- Time commitment
- The study lasts about six weeks: two weeks of baseline diet, followed by two weeks of the test diet with psyllium or glucose, with regular visits and sample collections during that time.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS
You likely can't join if
- Children who have had previous bowel surgery, have documented GI disorders (e.g., ulcerative colitis), or a serious chronic medical condition (e.g...
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Durham, North Carolina, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.