Status:
ACTIVE_NOT_RECRUITING
OptiMized REsistaNt Starch in Inflammatory Bowel Disease: the MEND Trial
Lead Sponsor:
Children's Hospital of Eastern Ontario
Conditions:
Crohn Disease
Ulcerative Colitis
Eligibility:
All Genders
5-17 years
Phase:
NA
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"...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04520594
Start Date
March 3 2021
End Date
December 1 2025
Last Update
February 18 2025
Active Locations (1)
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1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1