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To determine whether a specific food-origin plant-derived resistant starch (RS) optimized for the individual will increase the abundance of known butyrate producing microbes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistant Starch | Active Comparator | Once daily oral consumption of either 7.5g/m2 or 5.0g/m2 (body surface area) of a resistant starch for 48 weeks that is individually optimized at 24 weeks. |
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| Placebo | Placebo Comparator | Once daily oral consumption of a readily digestible food-grade cornstarch that resembles the study product in appearance, smell and taste for 48 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistant Starch | Other | 7.5g/m2 or 5.0g/m2 (body surface area) resistant starch oral consumption |
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| Measure | Description | Time Frame |
|---|---|---|
| Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis | Measures of restoration and sustainment of butyrate production by using metaproteomic/transcription to assess the expression of enzymes invovled in butyrate production | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks. |
| Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis | Measures of restoration and sustainment of butyrate production by using metabolomics analysis to assess production of short-chain-fatty acids including butyrate. | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks. |
| Measure of butyrate production by assessing increases in butyrate producers using metagenomics/16S analysis | Measures of restoration and sustainment of butyrate production by metagenomics/16s analysis to assess increases in butyrate producers | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in intensification as measured by anti-TNFa dose escalation | To help contextualize the anti-TNFa dose escalation (if applicable), Infliximab or adalimumab information will be recorded at baseline, 12 weeks, 24 weeks, 36 weeks and 48 weeks after start of study product. Type of anti-TNFa drug prescribed, amount of anti-TNFa prescribed, dose changes in timing of administration, trough drug serum levels, weight changes and reason for dose changes will be recorded |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| 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, pilot trial
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The treating physician, study participants, and research coordinators and lab researchers will not have knowledge of the randomization codes and will be blinded as to study product allocation. Unblinding will occur only if necessary to ensure study participants safety. Only Dr. Mack (Co-PI) will request to break the blind for safety reasons. Once the blind is broken by Dr. Mack the patient will be discontinued from study product.
| Placebo | Other | Placebo oral consumption of food-grade cornstarch |
|
| Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks |
| Change in intensification as measured by anti-TNFa interval shortening | To help contextualize the anti-TNFa interval shortening (if applicable), Infliximab or adalimumab information will be recorded at baseline, 12 weeks, 24 weeks, 36 weeks and 48 weeks after start of study product. Type of anti-TNFa drug prescribed, amount of anti-TNFa prescribed, dose changes in timing of administration, trough drug serum levels, weight changes and reason for dose changes will be recorded | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks |
| Change in disease activity | 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). | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks |
| Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples | Measure of fecal calprotectin | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks |
| Changes in biomarkers of inflammation by measuring c-reactive protein through blood samples | Measure of c-reactive protein | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks |
| 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. | Baseline, 24 weeks, 48 weeks |
| Changes in patient reported quality of life outcomes as measured by the IMPACT III Questionnaire | 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. | Baseline, 24 weeks, 48 weeks |
| Changes in parent/caregiver reported quality of life outcomes as measured by the IMPACT III-P | The IMPACT III-P 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. | Baseline, 24 weeks, 48 weeks |
| 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 |