Back to resultsOptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial
Primary Purpose
Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Resistant Starch
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Crohn Disease focused on measuring Resistant Starch, Microbiome
Eligibility 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.
Sites / Locations
- Children's Hospital of Eastern OntarioRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Resistant Starch
Placebo
Arm Description
Once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch for approximately 6 months
Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 6 months
Outcomes
Primary Outcome Measures
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
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.
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.
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.
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.
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.
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.
The Physician Global Assessment (PGA) ranges from 0 to 3 points (0 = normal, 1 = mild, 2 = moderate, 3 = severe).
Full Information
NCT ID
NCT04520594
First Posted
July 31, 2020
Last Updated
July 19, 2022
Sponsor
Children's Hospital of Eastern Ontario
1. Study Identification
Unique Protocol Identification Number
NCT04520594
Brief Title
OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial
Official Title
OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Eastern Ontario
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
Keywords
Resistant Starch, Microbiome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A single center, randomized, placebo-controlled, double-blinded, parallel, pilot clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Unblinding will occur only if necessary to ensure study participants safety, interim analysis at 5 ± 1 months, or eligibility for our associated open label trail (OARS trial). Only Dr. Mack (Co-PI) can request to break the blind for safety reasons or eligibility for the OARS Trial; only Dr. Stintzi (Co-PI) will request to break the blind for interim analysis. Once the blind is broken, the patient will be discontinued from study product.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Resistant Starch
Arm Type
Active Comparator
Arm Description
Once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch for approximately 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 6 months
Intervention Type
Other
Intervention Name(s)
Resistant Starch
Intervention Description
7.5 g resistant starch/m2 oral consumption
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo oral consumption of food-grade cornstarch
Primary Outcome Measure Information:
Title
Increased potential of butyrate production following the use of individualized resistant starch, as assessed by meta-omics analysis.
Time Frame
6 ± 1 months
Title
Sustained potential for butyrate production following 6 months use of individualized resistant starch post randomization as assessed by meta-omics analysis.
Time Frame
12 ± 2 months
Title
Change in microbiome composition of cases towards the microbiome of controls as assessed by meta-omics analysis.
Time Frame
6 ± 1 months and 12 ± 2 months
Secondary Outcome Measure Information:
Title
Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire.
Description
The IBD disability index consists of 28 questions and a higher overall score is indicative of greater disability.
Time Frame
Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
Title
Changes in patient, parent/caregiver reported quality of life outcomes as measured by the IMPACT III Questionnaires.
Description
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.
Time Frame
Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
Title
Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples.
Time Frame
Enrollment, 3 ± 1 months, 6 ± 1 months, 9 ± 1 months, and 12 ± 2 months
Title
Change in clinical disease activity as measured by the wPCDAI for Crohn's Disease.
Description
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).
Time Frame
Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
Title
Change in clinical disease activity as measured by the PUCAI for Ulcerative Colitis.
Description
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).
Time Frame
Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
Title
Change in clinical disease activity as measured by the Partial Mayo Score for Ulcerative Colitis.
Description
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).
Time Frame
Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
Title
Change in clinical disease activity as measured by the PGA for both Crohn's Disease and Ulcerative Colitis.
Description
The Physician Global Assessment (PGA) ranges from 0 to 3 points (0 = normal, 1 = mild, 2 = moderate, 3 = severe).
Time Frame
Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Mack, MD, FRCPC
Phone
(613) 737-7600
Ext
2516
Email
dmack@cheo.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Singleton
Phone
(613) 737-7600
Ext
4123
Email
rsingleton@cheo.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mack, MD, FRCPC
Organizational Affiliation
Children's Hospital of Eastern Ontario
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alain Stintzi, PhD
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Singleton
Phone
(613) 737-7600
Ext
4123
Email
rsingleton@cheo.on.ca
12. IPD Sharing Statement
Learn more about this trial
OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial
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