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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
100
7.5 g resistant starch/m2 oral consumption
Placebo oral consumption of food-grade cornstarch
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Increased potential of butyrate production following the use of individualized resistant starch, as assessed by meta-omics analysis.
Time frame: 6 ± 1 months
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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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
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).
Time frame: 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).
Time frame: 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).
Time frame: Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months