Recruiting

B-fructan Diet

Sponsor:

University of Manitoba

Code:

NCT05615779

Conditions

Inflammatory Bowel Diseases

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 6 - 39

Healthy Volunteers: Accepted

Interventions

Placebo Comparator: Randomized pectin diet

Randomized B-fructan diet

Personalized pectin diet

Personalized B-fructan diet

Study Details

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.

Conditions

Inflammatory Bowel Diseases

Ulcerative Colitis

Study ID

NCT05615779

Start date

Aug 1, 2023

Status verified date

Dec, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 39

Healthy Volunteers: Accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Randomized pectin diet

placebo comparator: Randomized B-fructan diet

experimental: Personalized pectin diet

experimental: Personalized B-fructan diet

Interventions

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

Primary outcome measure

  • Diet tolerability [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Heather Armstrong, MSc, PhD

2047893815heather.armstrong@umanitoba.ca

Eytan Wine, MD, PhD

wine@umanitoba.ca

Locations

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 1C9

Contacts

Eytan Wine, MD, PhD

780-407-3339wine@ualberta.ca

Health Sciences Centre Hospital

Recruiting

Winnipeg, Manitoba, Canada, R3E 3P4

Contacts

Heather Armstrong, PhDMED

2047893815heather.armstrong@umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Apr 6, 2025

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2025-04-06.