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NCT Number: NCT05615779

Personalized B-fructan Diet in Inflammatory Bowel Disease Patients

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.

Recruiting

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Ulcerative Colitis

Age range

6 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Comparator: Randomized pectin diet

Other

UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in pectin

Randomized B-fructan diet

Other

UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in B-fructan

Personalized pectin diet

Other

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

Personalized B-fructan diet

Other

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 outcomes

  1. 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

  1. Inflammatory response to diet

    Time frame: 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

  2. Microbiota changes in response to diet

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eytan Wine, MD, PhD

CONTACT

[email protected]

Heather Armstrong, MSc, PhD

CONTACT

[email protected]

2047893815

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

The Fibre Study: RCT of Personalized Fibre Diet in IBD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2022
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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