Personalized B-fructan Diet in Inflammatory Bowel Disease Patients

NCT ID: NCT05615779

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Diseases Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Randomized pectin diet

Group Type PLACEBO_COMPARATOR

Placebo Comparator: Randomized pectin diet

Intervention Type OTHER

UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in pectin

Randomized B-fructan diet

Group Type PLACEBO_COMPARATOR

Randomized B-fructan diet

Intervention Type OTHER

UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in B-fructan

Personalized pectin diet

Group Type EXPERIMENTAL

Personalized pectin diet

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Personalized B-fructan diet

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status RECRUITING

Health Sciences Centre Hospital

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Heather Armstrong, MSc, PhD

Role: CONTACT

2047893815

Eytan Wine, MD, PhD

Role: CONTACT

Facility Contacts

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Eytan Wine, MD, PhD

Role: primary

780-407-3339

Heather Armstrong, PhDMED

Role: primary

2047893815

Other Identifiers

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B2022:074

Identifier Type: -

Identifier Source: org_study_id

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