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

NCT04522271 | Active Not Recruiting

• 1 other identifier: 20/04E
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

Keywords

Resistant Starch; Microbiome

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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%.

  Enrollment

• Compliance of resistant starch intake by patient report.

  5 ± 1 months

• Compliance of resistant starch intake by product reconciliation.

  5 ± 1 months

Secondary Outcomes (8)

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

  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.

  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.

  Enrollment, 5 ± 1 months, and 12 ± 2 months

• Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire.

  Enrollment, 5 ± 1 months, and 12 ± 2 months

• Changes in patient, parent/caregiver reported quality of life outcomes as measured by the IMPACT III Questionnaires.

  Enrollment, 5 ± 1 months, and 12 ± 2 months

Study Arms (2)

Resistant Starch

ACTIVE COMPARATOR

Once daily oral consumption of 7.5 g/m2 of an individually optimized resistant starch for approximately 5 months

Other: Resistant Starch

Placebo

PLACEBO COMPARATOR

Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 5 months

Other: Placebo

Interventions

Resistant Starch OTHER

7.5 g resistant starch/m2 oral consumption

Resistant Starch

Placebo OTHER

Placebo oral consumption of food-grade cornstarch

Placebo

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify 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 qualify 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.

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Resistant Starch

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• David Mack, MD, FRCPC

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

• Alain Stintzi, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Unblinding will occur only if necessary to ensure study participants safety, interim analysis at 5 ± 1 months, or eligibility for our associated open label trial (OARS trial). Only Dr. Mack (Co-PI) can request to break the blind for safety reasons or eligibility for the OARS Trial; only Dr Stintzi (Co-PI) will request to break the blind for interim analysis. Once the blind is broken, the patient will be discontinued from study product.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, CHEO IBD Centre

Model Details: A single center, randomized, placebo-controlled, double-blinded, parallel, pilot clinical trial

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 21, 2020
• Study Start: August 25, 2020
• Primary Completion: May 25, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)