Ireland
--:--IST
Active, not recruiting Not applicable

OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial

NCT04520594 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2021-03-03
Last updated
2026-01-29

Condition(s) studied

Crohn DiseaseUlcerative ColitisInflammatory Bowel Diseases

Investigational drug(s) / intervention(s)

Resistant StarchPlacebo

Resistant Starch: 7.5 g resistant starch/m2 oral consumption

Placebo: Placebo oral consumption of food-grade cornstarch

Study 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.

Eligibility

Sex
ALL
Min age
5 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Children's Hospital of Eastern Ontario Ottawa Ontario
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04520594 on ClinicalTrials.gov ↗ ← All trials in Canada