Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Children's Hospital of Eastern Ontario
Age
5–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
