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The purpose of the study is 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistant Starch | Active Comparator | Once daily oral consumption of 7.5 g/m2 of an individually optimized resistant starch for approximately 5 months |
|
| Placebo | Placebo Comparator | Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 5 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistant Starch | Other | 7.5 g resistant starch/m2 oral consumption |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Increased potential for butyrate production and its level at the mucosal luminal interface following ingestion of an individualized resistant starch as assessed by meta-omics analysis. | 5 ± 1 months | |
| Sustained increased potential of butyrate production 6 months following cessation of the use of individualized resistant starch as assessed by meta-omics analysis of stools. | 12 ± 2 months | |
| The percentage of eligible inflammatory bowel disease (IBD) patients who will enter a resistant starch-based ingestion trial. | Threshold of interest will be 50%. | Enrollment |
| Compliance of resistant starch intake by patient report. | 5 ± 1 months | |
| Compliance of resistant starch intake by product reconciliation. | 5 ± 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbiome composition of cases towards the microbiome of controls as assessed by meta-omics analysis. | 5 ± 1 months and 12 ± 2 months | |
| Changes in mitochondrial function due to ingestion of resistant starch as assessed by host proteomics of biopsy sampling. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Mack, MD, FRCPC | Children's Hospital of Eastern Ontario | Principal Investigator |
| Alain Stintzi, PhD | University of Ottawa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000084922 | Resistant Starch |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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A single center, randomized, placebo-controlled, double-blinded, parallel, pilot clinical trial
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Unblinding will occur only if necessary to ensure study participants safety, interim analysis at 5 ± 1 months, or eligibility for our associated open label trial (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.
| Placebo |
| Other |
Placebo oral consumption of food-grade cornstarch |
|
| Enrollment, and 5 ± 1 months |
| Change in clinical disease activity as measured by the wPCDAI for Crohn's Disease, the PUCAI and Partial Mayo Score for Ulcerative Colitis, and the PGA for both Crohn's Disease and Ulcerative Colitis. | 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). 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). 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). The Physician Global Assessment (PGA) ranges from 0 to 3 points (0 = normal, 1 = mild, 2 = moderate, 3 = severe). | Enrollment, 5 ± 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. | Enrollment, 5 ± 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. | Enrollment, 5 ± 1 months, and 12 ± 2 months |
| Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples. | Enrollment, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, and 12 months |
| Change in endoscopic disease activity measured during colonoscopies using the SES-CD for Crohn's Disease and the Mayo Endoscopic Sub Score and UCEIS for Ulcerative Colitis. | The Simple Endoscopic Score for Crohn's Disease (SES-CD) measures disease inflammation (0 to 2= inactive, 3 to 6 = mild, 7 to 15 = moderate, >16 = severe). Mayo Endoscopic Sub Scores range from 0 to 3, with 0 representing a normal mucosa or inactive disease and 3 representing severe activity (spontaneous bleeding and large ulcerations). The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ranges from 0 to 8 (0 to 1 = remission, 2 to 4 = mild, 5 to 6 = moderate, and 7 to 8 = severe). | Enrollment, and 5 ± 1 months |
| Change in histological scoring of acute and chronic inflammation collected through biopsies during colonoscopies and assessed using Naini and Cortina score for Crohn's disease and the Robarts Histopathological Index (RHI) for Ulcerative Colitis. | The Naini and Cortina score ranges from 0 to 10 for ileitis and 0 to 17 for colitis. For ileitis, the histopathological support for having IBD is either low (score < 2), moderate (score is 3 to 4), or high (score ≥ 5). For colitis, the likelihood of having IBD is either low (≤3), moderate (score is 4 to 8), or high (score ≥ 9). The Robarts Histopathological Index score ranges from 0 to 33 with a higher score representing more severe inflammation. | Enrollment, and 5 ± 1 months |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| Macromolecular Substances |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |