Using psyllium to treat irritable bowel syndrome in children
Assessing Psyllium Given With Meals for Fructan Sensitivity in Children With Irritable Bowel Syndrome
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 |
| Enrollment | 110 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06639984 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 12-17 who meet the pediatric Rome IV criteria for IBS.
Not a fit: Patients with serious chronic medical conditions or documented gastrointestinal disorders may not benefit from this study.
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 performed: Previous studies have shown promise in using dietary fibers for managing IBS symptoms, suggesting this approach may be effective.
Eligibility criteria
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 this trial is running
Durham, North Carolina
- 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: 919-681-8739
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.