Personalized B-fructan Diet in Inflammatory Bowel Disease Patients
Recruiting · NCT05615779 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Manitoba
View the official record on ClinicalTrials.gov →Interventions studied
Personalized B-fructan dietPersonalized pectin dietPlacebo Comparator: Randomized pectin dietRandomized B-fructan diet
What this trial is about
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.
Who can take part
Age range
6 Years to 39 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed.
- University of Alberta Hospital - Edmonton, Alberta, Canada
- Health Sciences Centre Hospital - Winnipeg, Manitoba, Canada