OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial

  • STATUS
    Recruiting
  • End date
    Feb 26, 2024
  • participants needed
    100
  • sponsor
    Children's Hospital of Eastern Ontario
Updated on 4 October 2022
Investigator
David Mack, MD
Primary Contact
Children's Hospital of Eastern Ontario (5.8 mi away) Contact
remission
ulcerative colitis
inflammatory bowel disease
crohn's disease
enteropathy
colitis
ulceration

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.

Details
Condition Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
Treatment Placebo, Resistant starch
Clinical Study IdentifierNCT04520594
SponsorChildren's Hospital of Eastern Ontario
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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