Personalized B-fructan Diet in Inflammatory Bowel Disease Patients
Not applicable · Testing Randomized B-fructan diet, Personalized pectin diet and Personalized B-fructan diet · 2 sites · University of Manitoba
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Randomized B-fructan diet, Personalized pectin diet and Personalized B-fructan diet to better understand how the disease works. Condition(s) listed: Inflammatory Bowel Diseases and Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 6 to 39
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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
Plus 4 more requirement(s). There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 600 participants are expected to take part.
- Start date: 2023-08-01.
- Main results expected around 2025-12-01 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in Canada.
Main thing being measured
- Diet tolerability (4 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases; Ulcerative Colitis |
| Lead sponsor | University of Manitoba |
| Enrollment | 600 (estimated) |
| Start date | 2023-08-01 |
| Primary completion (est.) | 2025-12-01 |
| First posted | 2022-11-14 |
| Last updated | 2025-04-06 |
| Official title | The Fibre Study: RCT of Personalized Fibre Diet in IBD |
| ClinicalTrials.gov ID | NCT05615779 |
Interventions
- Placebo Comparator: Randomized pectin diet (Other)
UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in pectin - Randomized B-fructan diet (Other)
UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in B-fructan - Personalized pectin diet (Other)
UC and healthy control participants to receive recommendations provided by a dietician increasing consumption of foods high in pectin based on personal host (biopsy) and microbe (stool) response at baseline - Personalized B-fructan diet (Other)
UC and healthy control participants to receive recommendations provided by a dietician increasing consumption of foods high in B-fructan based on personal host (biopsy) and microbe (stool) response at baseline
Full eligibility criteria (from the record)
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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Hospital | Edmonton, Alberta | Canada | Recruiting |
| Health Sciences Centre Hospital | Winnipeg, Manitoba | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.