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NCT05615779
Personalized B-fructan Diet in Inflammatory Bowel Disease Patients
Conditions: Inflammatory Bowel Diseases, Ulcerative Colitis
Sex: All
Ages: 6 Years – 39 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 600
Sponsor: University of Manitoba
Summary
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.
Eligibility 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 <10Clinical indication for sedated colonoscopyDisease location: E2-E4Stable 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 dataExclusion Criteria:Use of antibiotics for a week or more over the last 3 monthsUse 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 appendectomyDocumented enteric infection during the 3 months prior to endoscopyPresence of non-IBD bowel conditions (e.g., celiac), anatomical or mucosal abnormalities, motility disorderPresence 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 endoscopyRecent change in IBD treatment (started biologics or IM over the last month)Pregnancy or planning to become pregnant during the studyInability to understand or sign the consent
Source: ClinicalTrials.gov (NCT05615779). StuddyBuddy aggregates publicly available trial information.