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

N/AActive Not RecruitingNCT04522271

Children's Hospital of Eastern Ontario80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Crohn Disease Ulcerative Colitis Inflammatory Bowel Diseases

Interventions

Resistant StarchOTHER

7.5 g resistant starch/m2 oral consumption

PlaceboOTHER

Placebo oral consumption of food-grade cornstarch

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 5 ± 1 months

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.

Time frame: 12 ± 2 months

The percentage of eligible inflammatory bowel disease (IBD) patients who will enter a resistant starch-based ingestion trial.

Threshold of interest will be 50%.

Time frame: Enrollment

Compliance of resistant starch intake by patient report.

Time frame: 5 ± 1 months

Compliance of resistant starch intake by product reconciliation.

Time frame: 5 ± 1 months

Secondary Outcomes

Change in microbiome composition of cases towards the microbiome of controls as assessed by meta-omics analysis.

Time frame: 5 ± 1 months and 12 ± 2 months

Changes in mitochondrial function due to ingestion of resistant starch as assessed by host proteomics of biopsy sampling.

Time frame: Enrollment, and 5 ± 1 months

Change in clinical disease activity as measured by the wPCDAI for Crohn's Disease, the PUCAI and Partial Mayo Score for Ulcerative Colitis, and the PGA for both Crohn's Disease and Ulcerative Colitis.

Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) ranges from 0 to 125 points (\<12.5 = remission, 12.5 to 40.0 = mild, \>40.0 = moderate, \>57.5 = severe). The Pediatric Ulcerative Colitis Activity Index (PUCAI) ranges from 0 to 85 points (\<10 = remission, 10 to 34 = mild, 35 to 64= moderate, \>65 = severe). Partial Mayo Score ranges from 0 to 9 points (0 to 1 = remission, 2 to 4 = mild, 5 to 6 = moderate, 7 to 9 = severe). The Physician Global Assessment (PGA) ranges from 0 to 3 points (0 = normal, 1 = mild, 2 = moderate, 3 = severe).

Data from ClinicalTrials.gov

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