Personalized B-fructan Diet in Inflammatory Bowel Disease Patients

Sponsor

University of Manitoba (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05615779

Collaborator

(none)

600

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Ulcerative Colitis	Other: Placebo Comparator: Randomized pectin diet Other: Randomized B-fructan diet Other: Personalized pectin diet Other: Personalized B-fructan diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

The Fibre Study: RCT of Personalized Fibre Diet in IBD

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 39 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Manitoba

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Manitoba

ClinicalTrials.gov Identifier:

NCT05615779

Other Study ID Numbers:

B2022:074

First Posted:

Nov 14, 2022

Last Update Posted:

Nov 14, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Intestinal Diseases

Inflammatory Bowel Diseases

Levan

Study Results

No Results Posted as of Nov 14, 2022