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

Children's Hospital of Eastern Ontario

Status

Active, not recruiting

Conditions

Ulcerative Colitis

Inflammatory Bowel Diseases

Crohn Disease

Treatments

Other: Resistant Starch

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04522271

20/04E

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

5 to 17 years old

Volunteers

No 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.
Refusal to undergo follow-up colonoscopy as part of current clinical practice guidelines for Crohn's Disease standard of care.