Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Brief 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.
Interventions
OTHERPlacebo Comparator: Randomized pectin diet
UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in pectin
OTHERRandomized B-fructan diet
UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in B-fructan
OTHERPersonalized 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
OTHERPersonalized 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
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diet tolerability | 4 weeks | Percentage of patients able to tolerate a personalized fiber diet provided by a dietitian will be evaluated at week 4 by measure of patient symptom score (PROMIS questionnaire) and willingness to continue adherence to diet advice provided. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory response to diet | 1 week, 4 weeks, 8 weeks, 12 weeks | Host inflammatory response to personalized dietary fibre recommendations provided by dietitian will be determined by examining changes in markers of inflammation in blood and stool |
| Microbiota changes in response to diet | 1 week, 4 weeks, 8 weeks, 12 weeks | Host microbiota response to personalized dietary fibre recommendations provided by dietitian will be determined by examining changes in microbe abundance, diversity and functions by shotgun metagenomics in stool |
Countries
Canada
Contacts
Primary ContactHeather Armstrong, MSc, PhD
Backup ContactEytan Wine, MD, PhD
Outcome results
None listed