OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial
NCT04520594 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-01-29
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
Interventions
- OTHER
-
Resistant Starch
7.5 g resistant starch/m2 oral consumption
- OTHER
-
Placebo
Placebo oral consumption of food-grade cornstarch
Sponsors & Collaborators
-
Children's Hospital of Eastern Ontario
lead OTHER
Principal Investigators
-
David Mack, MD, FRCPC · Children's Hospital of Eastern Ontario
-
Alain Stintzi, PhD · University of Ottawa
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-03
- Primary Completion
- 2024-11-05
- Completion
- 2026-12-31
Countries
- Canada
Study Locations
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