OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial

NCT04520594 | Active Not Recruiting

• 1 other identifier: 20/16E
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to 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 (3)

• Increased potential of butyrate production following the use of individualized resistant starch, as assessed by meta-omics analysis.

  6 ± 1 months

• Sustained potential for butyrate production following 6 months use of individualized resistant starch post randomization as assessed by meta-omics analysis.

  12 ± 2 months

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

  6 ± 1 months and 12 ± 2 months

Secondary Outcomes (7)

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

  Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months

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

  Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months

• Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples.

  Enrollment, 3 ± 1 months, 6 ± 1 months, 9 ± 1 months, and 12 ± 2 months

• Change in clinical disease activity as measured by the wPCDAI for Crohn's Disease.

  Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months

• Change in clinical disease activity as measured by the PUCAI for Ulcerative Colitis.

  Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months

Study Arms (2)

Resistant Starch

ACTIVE COMPARATOR

Once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch for approximately 6 months

Other: Resistant Starch

Placebo

PLACEBO COMPARATOR

Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 6 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.
• Existing Crohn's disease or ulcerative colitis diagnosis.
• In clinical remission or with mild disease (wPCDAI of 0-39.5 for CD; PUCAI of 0-30 for UC) with no changes in standard of care treatment for the previous month and without anticipated changes for the next month.
• 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.
• Concomitant chronic disease requiring medications.
• Requirement for antibiotic therapy \>2 weeks duration.
• Participant's microbiota does not respond to any of the resistant starch from the assembled panel as measured through the RapidAIM evaluation following the initial stool sample collection.
• Patients with previous intestinal surgery.

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 trail (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 20, 2020
• Study Start: March 3, 2021
• Primary Completion: November 5, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

CA (1)