OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increased potential of butyrate production following the use of individualized resistant starch, as assessed by meta-omics analysis.;Sustained potential for butyrate production following 6 months use of individualized resistant starch post randomization as assessed by meta-omics analysis.;Change in microbiome composition of cases towards the microbiome of controls as assessed by meta-omics analysis.

Secondary Outcome Measures

Name	Time	Method
Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire.;Changes in patient, parent/caregiver reported quality of life outcomes as measured by the IMPACT III Questionnaires.;Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples.;Change in clinical disease activity as measured by the wPCDAI for Crohn's Disease.;Change in clinical disease activity as measured by the PUCAI for Ulcerative Colitis.;Change in clinical disease activity as measured by the Partial Mayo Score for Ulcerative Colitis.;Change in clinical disease activity as measured by the PGA for both Crohn's Disease and Ulcerative Colitis.