Clinical trial NCT04520594: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Crohn Disease
Ulcerative Colitis
Inflammatory Bowel Diseases
Keywords: Resistant Starch
Microbiome
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single center, randomized, placebo-controlled, double-blinded, parallel, pilot clinical trial
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Increased potential of butyrate production following the use of individualized resistant starch, as assessed by meta-omics analysis.
timeFrame: 6 ± 1 months
measure: Sustained potential for butyrate production following 6 months use of individualized resistant starch post randomization as assessed by meta-omics analysis.
timeFrame: 12 ± 2 months
measure: Change in microbiome composition of cases towards the microbiome of controls as assessed by meta-omics analysis.
timeFrame: 6 ± 1 months and 12 ± 2 months
Secondary outcomes:
measure: Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire.
timeFrame: Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
measure: Changes in patient, parent/caregiver reported quality of life outcomes as measured by the IMPACT III Questionnaires.
timeFrame: Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
measure: Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples.
timeFrame: Enrollment, 3 ± 1 months, 6 ± 1 months, 9 ± 1 months, and 12 ± 2 months
measure: Change in clinical disease activity as measured by the wPCDAI for Crohn's Disease.
timeFrame: Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
measure: Change in clinical disease activity as measured by the PUCAI for Ulcerative Colitis.
timeFrame: Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
measure: Change in clinical disease activity as measured by the Partial Mayo Score for Ulcerative Colitis.
timeFrame: Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
measure: Change in clinical disease activity as measured by the PGA for both Crohn's Disease and Ulcerative Colitis.
timeFrame: Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: David Mack, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa
name: Alain Stintzi, PhD
role: PRINCIPAL_INVESTIGATOR
References: