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Recruiting NCT05615779

Personalized B-fructan Diet in Inflammatory Bowel Disease Patients

No phase Interventional Inflammatory Bowel Diseases Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo Comparator: Randomized pectin diet, Randomized B-fructan diet, Personalized pectin diet, Personalized B-fructan diet.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Diseases, Ulcerative Colitis. Basic parameters: 6 years — 39 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Fibre Study: RCT of Personalized Fibre Diet in IBD

Overview

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.

Interventions

  • 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
  • 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
  • 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
  • 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

Primary outcome measures

  • Diet tolerability [Time frame: 4 weeks]
Secondary outcome measures (2)
  • Inflammatory response to diet [Time frame: 1 week, 4 weeks, 8 weeks, 12 weeks]
  • Microbiota changes in response to diet [Time frame: 1 week, 4 weeks, 8 weeks, 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

Canada · 2 centers
  • University of Alberta Hospital — Edmonton
  • Health Sciences Centre Hospital — Winnipeg

Identifiers

NCT: NCT05615779 · B2022:074

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗