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

Not Applicable

Active, not recruiting

• Conditions: Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

• Registration Number: NCT04522271
• Lead Sponsor: Children's Hospital of Eastern Ontario

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-7-31
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Inclusion Criteria:<br><br> - Capable of giving informed consent, or if appropriate, have an acceptable<br> representative capable of giving consent on the participant's behalf.<br><br> - Enrolled in the main parent study.<br><br> - New ulcerative colitis diagnosis (mild/moderate) or Crohn's Disease diagnosis<br> (moderate/severe) with colonic disease with or without terminal ileum disease,<br> already started on oral corticosteroid or aminosalicylates for induction therapy at<br> a time following diagnostic colonoscopy.<br><br> - Clinically responsive to induction medical therapy at enrollment (Crohn's Disease<br> participants with a weighted pediatric Crohn's Disease activity index decrease of =<br> 17.5 points or ulcerative colitis participants with a pediatric ulcerative colitis<br> activity index decrease of = 15 points).<br><br> - Ability and willingness to comply with study procedures (e.g. stool collections) for<br> the entire length of the study.<br><br> - Willing to provide consent/assent for the collection of stool samples.<br><br>Exclusion Criteria:<br><br> - Allergy to resistant starch or excipients.<br><br> - Co-existing diagnosis with diabetes mellitus.<br><br> - Treatment with another investigational drug or intervention throughout the study.<br><br> - Current drug or alcohol dependence that, in the opinion of the site investigator,<br> would interfere with adherence to study requirements.<br><br> - Inability or unwillingness of an individual or legal guardian to give written<br> informed consent.<br><br> - Requirement for antibiotic therapy as part of standard Crohn's Disease therapy (i.e.<br> those patients with penetrating disease as manifested by intra-abdominal abscess or<br> perianal abscess).<br><br> - Requirement of oral antibiotics for other conditions (e.g. acne).<br><br> - Participant's microbiota does not produce butyrate in response to any of the<br> assembled panel of resistant starch as measured through the Rapid Assay of an<br> Individual's Microbiome (RapidAIM) evaluation following enrollment.<br><br> - Requirement of therapy other than oral corticosteroid / aminosalicylates for<br> induction therapy.<br><br> - Patients diagnosed with Inflammatory Bowel Disease-Unclassified.<br><br> - Refusal to undergo follow-up colonoscopy as part of current clinical practice<br> guidelines for Crohn's Disease standard of care.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increased potential for butyrate production and its level at the mucosal luminal interface following ingestion of an individualized resistant starch as assessed by meta-omics analysis.;Sustained increased potential of butyrate production 6 months following cessation of the use of individualized resistant starch as assessed by meta-omics analysis of stools.;The percentage of eligible inflammatory bowel disease (IBD) patients who will enter a resistant starch-based ingestion trial.;Compliance of resistant starch intake by patient report.;Compliance of resistant starch intake by product reconciliation.