NCT04520594Active, not recruiting
OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 31 Jul 2020
- Start date
- 3 Mar 2021
- Primary completion date
- 5 Nov 2024
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT04520594
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 3 Mar 2021 to the primary completion date, 5 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Concomitant chronic disease requiring medications.
- Requirement for antibiotic therapy \>2 weeks duration.
- Patients with previous intestinal surgery.
Other illness
- Allergy to resistant starch or excipients.
- Co-existing diagnosis with diabetes mellitus.
Other
- Inability or unwillingness of an individual or legal guardian to give written informed consent.
- 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.
Who the study is looking for
- 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.
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children'S Hospital Of Eastern Ontario Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.