Crohn Disease, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Keywords
Resistant Starch, Microbiome
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.
Interventions
OTHERResistant Starch
7.5 g resistant starch/m2 oral consumption
OTHERPlacebo
Placebo oral consumption of food-grade cornstarch
Sponsors
Children's Hospital of Eastern Ontario
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
Intervention model description
A single center, randomized, placebo-controlled, double-blinded, parallel, pilot clinical trial
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORDavid Mack, MD, FRCPC
Children's Hospital of Eastern Ontario
PRINCIPAL_INVESTIGATORAlain Stintzi, PhD
University of Ottawa
Outcome results
None listed