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Clinical Trials/NCT05615779
NCT05615779RecruitingNot Applicable

The Fibre Study: RCT of Personalized Fibre Diet in IBD

University of Manitoba2 sites in 1 country600 target enrollmentStarted: August 1, 2023Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
600
Locations
2
Primary Endpoint
Diet tolerability
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
6 Years to 39 Years (Child, Adult)
Sex
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

Arms & Interventions

Randomized pectin diet

Placebo Comparator

Intervention: Placebo Comparator: Randomized pectin diet (Other)

Randomized B-fructan diet

Placebo Comparator

Intervention: Randomized B-fructan diet (Other)

Personalized pectin diet

Experimental

Intervention: Personalized pectin diet (Other)

Personalized B-fructan diet

Experimental

Intervention: Personalized B-fructan diet (Other)

Outcomes

Primary Outcomes

Diet tolerability

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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