OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial
Study Details
Study Description
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" gut microbiome in pediatric participants with inflammatory bowel disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Resistant Starch Once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch for approximately 6 months |
Other: Resistant Starch
7.5 g resistant starch/m2 oral consumption
|
| Placebo Comparator: Placebo Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 6 months |
Other: Placebo
Placebo oral consumption of food-grade cornstarch
|
Outcome Measures
Primary Outcome Measures
- 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
- Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire. [Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months]
The IBD disability index consists of 28 questions and a higher overall score is indicative of greater disability.
- Changes in patient, parent/caregiver reported quality of life outcomes as measured by the IMPACT III Questionnaires. [Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months]
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.
- 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. [Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months]
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).
- Change in clinical disease activity as measured by the PUCAI for Ulcerative Colitis. [Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months]
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).
- Change in clinical disease activity as measured by the Partial Mayo Score for Ulcerative Colitis. [Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months]
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).
- Change in clinical disease activity as measured by the PGA for both Crohn's Disease and Ulcerative Colitis. [Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months]
The Physician Global Assessment (PGA) ranges from 0 to 3 points (0 = normal, 1 = mild, 2 = moderate, 3 = severe).
Eligibility Criteria
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.
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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.
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Ability and willingness to comply with study procedures (e.g. stool collections) for the entire length of the study.
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Willing to provide consent/assent for the collection of stool samples.
Exclusion Criteria:
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Allergy to resistant starch or excipients.
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Co-existing diagnosis with diabetes mellitus.
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Treatment with another investigational drug or intervention throughout the study.
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Current drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
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Inability or unwillingness of an individual or legal guardian to give written informed consent.
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Concomitant chronic disease requiring medications.
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Requirement for antibiotic therapy >2 weeks duration.
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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.
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Patients with previous intestinal surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Eastern Ontario | Ottawa | Ontario | Canada | K1H 8L1 |
Sponsors and Collaborators
- Children's Hospital of Eastern Ontario
Investigators
- Principal Investigator: David Mack, MD, FRCPC, Children's Hospital of Eastern Ontario
- Principal Investigator: Alain Stintzi, PhD, University of Ottawa
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20/16E