Personalized B-fructan Diet in Inflammatory Bowel Disease Patients

Ulcerative Colitis Clinical Trial

Official title:

The Fibre Study: RCT of Personalized Fibre Diet in IBD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615779
• Other study ID #: B2022:074
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: October 2023
• Source: University of Manitoba
• Contact: Heather Armstrong, MSc, PhD
• Phone: 2047893815
• Email: heather.armstrong[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Health Sciences Centre Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet tolerability	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.	4 weeks
Secondary	Inflammatory response to diet	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	1 week, 4 weeks, 8 weeks, 12 weeks
Secondary	Microbiota changes in response to diet	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	1 week, 4 weeks, 8 weeks, 12 weeks