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Personalized B-fructan Diet in Inflammatory Bowel Disease Patients

Primary Purpose

Inflammatory Bowel Diseases, Ulcerative Colitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo Comparator: Randomized pectin diet
Randomized B-fructan diet
Personalized pectin diet
Personalized B-fructan diet
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammatory Bowel Diseases

Eligibility Criteria

6 Years - 39 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Randomized pectin diet

    Randomized B-fructan diet

    Personalized pectin diet

    Personalized B-fructan diet

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    October 4, 2022
    Last Updated
    May 17, 2023
    Sponsor
    University of Manitoba
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05615779
    Brief Title
    Personalized B-fructan Diet in Inflammatory Bowel Disease Patients
    Official Title
    The Fibre Study: RCT of Personalized Fibre Diet in IBD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    September 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Manitoba

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammatory Bowel Diseases, Ulcerative Colitis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Randomized pectin diet
    Arm Type
    Placebo Comparator
    Arm Title
    Randomized B-fructan diet
    Arm Type
    Placebo Comparator
    Arm Title
    Personalized pectin diet
    Arm Type
    Experimental
    Arm Title
    Personalized B-fructan diet
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Placebo Comparator: Randomized pectin diet
    Intervention Description
    UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in pectin
    Intervention Type
    Other
    Intervention Name(s)
    Randomized B-fructan diet
    Intervention Description
    UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in B-fructan
    Intervention Type
    Other
    Intervention Name(s)
    Personalized pectin diet
    Intervention Description
    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
    Intervention Name(s)
    Personalized B-fructan diet
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Diet tolerability
    Description
    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.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Inflammatory response to diet
    Description
    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
    Time Frame
    1 week, 4 weeks, 8 weeks, 12 weeks
    Title
    Microbiota changes in response to diet
    Description
    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
    Time Frame
    1 week, 4 weeks, 8 weeks, 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heather Armstrong, MSc, PhD
    Phone
    2047893815
    Email
    heather.armstrong@umanitoba.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eytan Wine, MD, PhD
    Email
    wine@umanitoba.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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