NCT05615779Recruiting
Personalized B-fructan Diet in Inflammatory Bowel Disease Patients
The Fibre Study: RCT of Personalized Fibre Diet in IBD
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to examine patient tolerability of personalized dietary fibre consumption recommendations (high-pectin diet versus high-B-fructan diet based on personalized responses), provided by an IBD dietician, based on our novel translational research findings.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 4 Oct 2022
- Start date
- 1 Aug 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- University of Manitoba
- Diseases
- Ulcerative colitis
- NCT number
- NCT05615779
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 1 Aug 2023 to the primary completion date, 1 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Documented enteric infection during the 3 months prior to endoscopy
- Systemic steroids (above 10 mg/day of Prednisone)
- Topical therapy within 1 week of endoscopy
Other illness
- History of abdominal surgery, including appendectomy
- 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)
Other
- 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)
- Proctitis (E1)
- 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
Who the study is looking for
- 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
Age in the registry: 6 years to 39 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Health Sciences Centre Hospital Coordinator of this site? Confirm its status | Winnipeg | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.