Personalized B-fructan Diet in Inflammatory Bowel Disease Patients

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases
• Interventions: Other: Personalized pectin diet; Other: Personalized B-fructan diet; Other: Randomized B-fructan diet

• Registration Number: NCT05615779
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-14
• Study Start: 2023-08-01
• Status Verified: 2024-12
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized pectin diet	Personalized pectin diet	-
Personalized B-fructan diet	Personalized B-fructan diet	-
Randomized B-fructan diet	Randomized B-fructan diet	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Health Sciences Centre Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada