Personalized B-fructan Diet in Inflammatory Bowel Disease Patients

NCT05615779 | Recruiting

• 1 other identifier: B2022:074
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Inflammatory response to diet

  1 week, 4 weeks, 8 weeks, 12 weeks

• Microbiota changes in response to diet

  1 week, 4 weeks, 8 weeks, 12 weeks

Study Arms (4)

Randomized pectin diet

PLACEBO COMPARATOR

Other: Placebo Comparator: Randomized pectin diet

Randomized B-fructan diet

PLACEBO COMPARATOR

Other: Randomized B-fructan diet

Personalized pectin diet

EXPERIMENTAL

Other: Personalized pectin diet

Personalized B-fructan diet

EXPERIMENTAL

Other: Personalized B-fructan diet

Interventions

Placebo Comparator: Randomized pectin diet OTHER

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

Randomized pectin diet

Randomized B-fructan diet OTHER

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

Randomized B-fructan diet

Personalized pectin diet 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 pectin diet

Personalized B-fructan diet 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

Personalized B-fructan diet

Eligibility Criteria

• Age: 6 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (2)

University of Alberta Hospital

Edmonton, Alberta, T6G 1C9, Canada

RECRUITING

Health Sciences Centre Hospital

Winnipeg, Manitoba, R3E 3P4, Canada

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Heather Armstrong, MSc, PhD

CONTACT

2047893815; heather.armstrong@umanitoba.ca

Eytan Wine, MD, PhD

CONTACT

wine@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: November 14, 2022
• Study Start: August 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2024-12

Locations

CA (2)