Personalized B-fructan Diet in Inflammatory Bowel Disease Patients

The Fibre Study: RCT of Personalized Fibre Diet in IBD

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis
• Intervention / Treatment: Other: Placebo Comparator: Randomized pectin diet; Other: Randomized B-fructan diet; Other: Personalized pectin diet; Other: Personalized B-fructan diet

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Armstrong, MSc, PhD; Phone Number: 2047893815; Email: heather.armstrong@umanitoba.ca
• Study Contact Backup: Name: Eytan Wine, MD, PhD; Email: wine@umanitoba.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C9
      • Recruiting
      • University of Alberta Hospital
      • Contact: Eytan Wine, MD, PhD; Phone Number: 780-407-3339; Email: wine@ualberta.ca
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Recruiting
      • Health Sciences Centre Hospital
      • Contact: Heather Armstrong, PhDMED; Phone Number: 2047893815; Email: heather.armstrong@umanitoba.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 39 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Randomized pectin diet	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
Placebo Comparator: Randomized B-fructan diet	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
Experimental: Personalized pectin diet	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
Experimental: Personalized B-fructan diet	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases; Antineoplastic Agents; Levan
• Other Study ID Numbers: B2022:074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No