Personalized dietary fiber recommendations for patients with inflammatory bowel disease
The Fibre Study: RCT of Personalized Fibre Diet in IBD
This study tests if personalized fiber diets can help children and young adults with inflammatory bowel disease feel better and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 6 Years to 39 Years |
| Sex | All |
| Sponsor | University of Manitoba Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 2 sites (Edmonton, Alberta and 1 other locations) |
| Trial ID | NCT05615779 on ClinicalTrials.gov |
What this trial studies
This study examines how well patients with inflammatory bowel diseases, specifically ulcerative colitis, tolerate personalized dietary fiber recommendations. Participants will be assigned to different diet groups, including high-pectin and high-B-fructan diets, based on their individual responses. The dietary plans are developed by an IBD dietician and aim to improve patient outcomes through tailored nutrition. The study will involve children and young adults who are in remission or have mild to moderate disease.
Who should consider this trial
Good fit: Ideal candidates include children aged 6-17 and young adults aged 18-39 with known or suspected ulcerative colitis or inflammatory bowel disease.
Not a fit: Patients with a history of abdominal surgery or those currently using antibiotics or probiotics at pharmacological doses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved dietary management and quality of life for patients with inflammatory bowel diseases.
How similar studies have performed: While personalized dietary interventions in IBD are gaining interest, this specific approach is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children (age 6-17) or young adults (age 18-39). * Known or suspected UC or IBDU \[there will be 2 control group: non-IBD (undergoing colonoscopy but found not to have IBD; and healthy (no GI symptoms, so not required to have colonoscopy; could be family members)\] * For UC: Remission-mild-moderate disease: Mayo score \<10 * Clinical indication for sedated colonoscopy * Disease location: E2-E4 * Stable treatment (not on steroids; biologics or immunomodulator not changed in last month) * High likelihood that patients will be able to collect all samples and provide all data Exclusion Criteria: * Use of antibiotics for a week or more over the last 3 months * Use of probiotics or prebiotics at pharmacological doses (adding fibre sources to food or probiotics in yogurt, for example, are allowed) * History of abdominal surgery, including appendectomy * Documented enteric infection during the 3 months prior to endoscopy * Presence of non-IBD bowel conditions (e.g., celiac), anatomical or mucosal abnormalities, motility disorder * Presence of a systemic disease requiring treatment (cancer, ischemic heart disease, kidney failure, etc) * Proctitis (E1) * Systemic steroids (above 10 mg/day of Prednisone) * Topical therapy within 1 week of endoscopy * Recent change in IBD treatment (started biologics or IM over the last month) * Pregnancy or planning to become pregnant during the study * Inability to understand or sign the consent
Where this trial is running
Edmonton, Alberta and 1 other locations
- University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
- Health Sciences Centre Hospital — Winnipeg, Manitoba, Canada (Recruiting)
Study contacts
- Study coordinator: Heather Armstrong, MSc, PhD
- Email: heather.armstrong@umanitoba.ca
- Phone: 2047893815
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.