Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistant Starch | Active Comparator | Once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch for approximately 6 months |
|
| Placebo | Placebo Comparator | Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 6 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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, 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000084922 | Resistant Starch |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
Not provided
Not provided
A single center, randomized, placebo-controlled, double-blinded, parallel, pilot clinical trial
Not provided
Not provided
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.
| Placebo |
| Other |
Placebo oral consumption of food-grade cornstarch |
|
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, 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. | 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. | 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). | 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). | 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). | 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). | Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 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 |