Using psyllium to treat irritable bowel syndrome in children
Official title: Assessing Psyllium Given With Meals for Fructan Sensitivity in Children With Irritable Bowel Syndrome
Run by Duke University · NCT06639984 · Data updated 2026-11-12
This study is testing if taking psyllium fiber can help children with irritable bowel syndrome feel better after eating foods that contain fructans.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | February 20, 2025 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | May 26, 2026 |
| Trial ID | NCT06639984 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 12-17 who meet the pediatric Rome IV criteria for IBS.
✕Probably not a fit
Patients with serious chronic medical conditions or documented gastrointestinal disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of psyllium, a type of fiber, on children aged 12-17 with irritable bowel syndrome (IBS) who experience symptoms after consuming fructans. The study aims to determine how psyllium influences the fermentation of fructans by gut bacteria and whether it can alleviate gastrointestinal symptoms associated with fructan intake. Participants will undergo a dietary assessment followed by a two-week intervention period where they will consume either psyllium or a placebo alongside fructans. The trial will measure various gastrointestinal and microbiome-related outcomes to evaluate the effectiveness of psyllium.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce IBS symptoms in children, improving their quality of life.
How similar studies have gone: Previous studies have shown promise in using dietary fibers for managing IBS symptoms, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS Exclusion Criteria: * 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)
Where it's running
-
Duke University
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Bruno Chumpitazi, MD, MPH — Duke University
- Study coordinator: Bruno Chumpitazi, MD, MPH
- Email: bruno.chumpitazi@duke.edu
- Phone: 919-660-1227
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity
This study looks to see if people with non-celiac wheat sensitivity have liver fat or fibrosis and how this relates to IBS/FD and celiac disease.
-
Repeated transcranial magnetic stimulation to treat diarrhea-predominant irritable bowel syndrome
This study will test whether repeated transcranial magnetic stimulation (rTMS) can reduce diarrhea, abdominal pain, and improve quality of life in adults with IBS-D.
-
Brenipatide (LY3537031) for IBS with constipation
This trial will test whether brenipatide (LY3537031), given by a small under-the-skin injection, helps adults with IBS-C have less belly pain and more normal bowel movements compared with a placebo.
-
Brenipatide (LY3537031) treatment for adults with IBS‑D
This will test whether brenipatide (LY3537031) given under the skin helps adults with IBS‑D reduce belly pain and improve stool consistency compared with placebo.
-
Camlipixant for IBS-D and IBS-M: a test in adults
This study tests camlipixant versus placebo in adults with IBS with diarrhea or mixed IBS to see if it helps reduce symptoms and is safe.
-
Defining Objective Markers of Dietary Compliance in IBS
This study tests whether a biomarker in stool or urine can reflect how much certain carbohydrates you eat, helping manage IBS.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.