Status:
ACTIVE_NOT_RECRUITING
Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
Lead Sponsor:
Children's Hospital of Eastern Ontario
Conditions:
Crohn Disease
Ulcerative Colitis
Eligibility:
All Genders
5-17 years
Phase:
NA
Brief Summary
The purpose of the study is determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gu...
Eligibility Criteria
Inclusion
- Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf.
- Enrolled in the main parent study.
- New ulcerative colitis diagnosis (mild/moderate) or Crohn's Disease diagnosis (moderate/severe) with colonic disease with or without terminal ileum disease, already started on oral corticosteroid or aminosalicylates for induction therapy at a time following diagnostic colonoscopy.
- Clinically responsive to induction medical therapy at enrollment (Crohn's Disease participants with a weighted pediatric Crohn's Disease activity index decrease of ≥ 17.5 points or ulcerative colitis participants with a pediatric ulcerative colitis activity index decrease of ≥ 15 points).
- Ability and willingness to comply with study procedures (e.g. stool collections) for the entire length of the study.
- Willing to provide consent/assent for the collection of stool samples.
Exclusion
- Allergy to resistant starch or excipients.
- Co-existing diagnosis with diabetes mellitus.
- Treatment with another investigational drug or intervention throughout the study.
- Current drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability or unwillingness of an individual or legal guardian to give written informed consent.
- Requirement for antibiotic therapy as part of standard Crohn's Disease therapy (i.e. those patients with penetrating disease as manifested by intra-abdominal abscess or perianal abscess).
- Requirement of oral antibiotics for other conditions (e.g. acne).
- Participant's microbiota does not produce butyrate in response to any of the assembled panel of resistant starch as measured through the Rapid Assay of an Individual's Microbiome (RapidAIM) evaluation following enrollment.
- Requirement of therapy other than oral corticosteroid / aminosalicylates for induction therapy.
- Patients diagnosed with Inflammatory Bowel Disease-Unclassified.
- Refusal to undergo follow-up colonoscopy as part of current clinical practice guidelines for Crohn's Disease standard of care.
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04522271
Start Date
August 25 2020
End Date
December 1 2025
Last Update
February 18 2025
Active Locations (1)
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1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1