OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial

Study Overview
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Brief Summary
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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.

Official Title
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OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial

Conditions
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Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases

Intervention / Treatment
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* Other: Resistant Starch
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A single center, randomized, placebo-controlled, double-blinded, parallel, pilot clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resistant Starch<br>Once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch for approximately 6 months | Other: Resistant Starch<br>* 7.5 g resistant starch/m2 oral consumption<br>|
| Placebo Comparator: Placebo<br>Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 6 months | Other: Placebo<br>* Placebo oral consumption of food-grade cornstarch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire. | The IBD disability index consists of 28 questions and a higher overall score is indicative of greater disability. | Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months | 
| Changes in patient, parent/caregiver reported quality of life outcomes as measured by the IMPACT III Questionnaires. | The IMPACT III questionnaire (a health related quality of life questionnaire) consists of 35 questions and ranges in score from 0 to 231. A higher score represents a higher quality of life. The IMPACT III-P Questionnaire is to be completed by the caregiver/guardian with a higher score also representing a higher quality of life. | Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months | 
| Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples. |  | Enrollment, 3 ± 1 months, 6 ± 1 months, 9 ± 1 months, and 12 ± 2 months | 
| Change in clinical disease activity as measured by the wPCDAI for Crohn's Disease. | Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) ranges from 0 to 125 points (<12.5 = remission, 12.5 to 40.0 = mild, >40.0 = moderate, >57.5 = severe). | Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months | 
| Change in clinical disease activity as measured by the PUCAI for Ulcerative Colitis. | The Pediatric Ulcerative Colitis Activity Index (PUCAI) ranges from 0 to 85 points (<10 = remission, 10 to 34 = mild, 35 to 64= moderate, >65 = severe). | Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months | 
| Change in clinical disease activity as measured by the Partial Mayo Score for Ulcerative Colitis. | The Partial Mayo Score ranges from 0 to 9 points (0 to 1 = remission, 2 to 4 = mild, 5 to 6 = moderate, 7 to 9 = severe). | Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months | 
| Change in clinical disease activity as measured by the PGA for both Crohn's Disease and Ulcerative Colitis. | The Physician Global Assessment (PGA) ranges from 0 to 3 points (0 = normal, 1 = mild, 2 = moderate, 3 = severe). | Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resistant Starch, Microbiome