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Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) | Clinical Trials | Clareo Health

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Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)

A Single Center, Randomized, Placebo-controlled, Double-blinded, Parallel, Pilot Clinical Trial to Assess Plant-derived Food-based Resistant Starches Individually Optimized for Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)

NCT04522271•Children's Hospital of Eastern Ontario

View on ClinicalTrials.gov

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" gut microbiome in pediatric participants with inflammatory bowel disease.

Eligibility

Age

5 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.
+1 more criteria

Locations (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Key Dates

Start Date

August 25, 2020

Primary Completion Date

May 25, 2024

Completion Date

December 31, 2026

Last Updated

January 29, 2026

Enrollment

ESTIMATED participants

Conditions

Crohn DiseaseUlcerative ColitisInflammatory Bowel Diseases

Interventions

Resistant Starch

OTHER

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)

Inclusion Criteria

Exclusion Criteria

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