OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Other: Resistant Starch; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Mack, MD, FRCPC; Phone Number: 2516 (613) 737-7600; Email: dmack@cheo.on.ca
• Study Contact Backup: Name: Ruth Singleton; Phone Number: 4123 (613) 737-7600; Email: rsingleton@cheo.on.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L1
      • Children's Hospital Of Eastern Ontario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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.
• 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.

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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Resistant Starch; Once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch for approximately 6 months	Other: Resistant Starch; 7.5 g resistant starch/m2 oral consumption
Placebo Comparator: Placebo; Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 6 months	Other: Placebo; Placebo oral consumption of food-grade cornstarch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire.	The IBD disability index consists of 28 questions and a higher overall score is indicative of greater disability.	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.	The IMPACT III questionnaire (a health related quality of life questionnaire) consists of 35 questions and ranges in score from 0 to 231. A higher score represents a higher quality of life. The IMPACT III-P Questionnaire is to be completed by the caregiver/guardian with a higher score also representing a higher quality of life.	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.	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).	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.	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).	Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
Change in clinical disease activity as measured by the Partial Mayo Score for Ulcerative Colitis.	The 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).	Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
Change in clinical disease activity as measured by the PGA for both Crohn's Disease and Ulcerative Colitis.	The Physician Global Assessment (PGA) ranges from 0 to 3 points (0 = normal, 1 = mild, 2 = moderate, 3 = severe).	Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months

Collaborators and Investigators

• Sponsor: Children's Hospital of Eastern Ontario
• Investigators: Principal Investigator: David Mack, MD, FRCPC, Children's Hospital Of Eastern Ontario; Principal Investigator: Alain Stintzi, PhD, University of Ottawa

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Microbiome; Resistant Starch
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: 20/16E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No