Personalized B-fructan Diet in Inflammatory Bowel Disease Patients
NCT ID: NCT05615779
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2023-08-01
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Randomized pectin diet
Placebo Comparator: Randomized pectin diet
UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in pectin
Randomized B-fructan diet
Randomized B-fructan diet
UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in B-fructan
Personalized pectin diet
Personalized pectin diet
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
Personalized B-fructan diet
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
Interventions
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Placebo Comparator: Randomized pectin diet
UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in pectin
Randomized B-fructan diet
UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in B-fructan
Personalized pectin diet
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
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
Eligibility Criteria
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Inclusion Criteria
* 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 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
6 Years
39 Years
ALL
Yes
Sponsors
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University of Manitoba
OTHER
Responsible Party
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Locations
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University of Alberta Hospital
Edmonton, Alberta, Canada
Health Sciences Centre Hospital
Winnipeg, Manitoba, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B2022:074
Identifier Type: -
Identifier Source: org_study_id
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