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| Name | Class |
|---|---|
| Wolfson Medical Center | OTHER_GOV |
| IWK Health Centre | OTHER |
| National Institutes of Health (NIH) | NIH |
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Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has long been considered to be due to a dysregulated immune response targeting the colon, and involves unknown environmental factors. Currently, no effective therapy targets the microbiota or its interaction with the colonic epithelium. Diet has a significant impact on the composition of the microbiota; however, no dietary intervention to date has proven effective for induction of remission. The primary objective of this study is to determine whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC patients with active mild to moderate UC on a stable medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulcerative Colitis Diet | Experimental | Participants will receive a structured 12-week diet with a step down phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulcerative Colitis Diet (UCD) | Other | The primary study intervention is a novel dietary intervention, the UC Diet. The UC Diet is a structured 12-week diet with a step down phase designed to remove products that allow harmful bacteria to thrive and add products that can change the bacteria in the gut to induce remission |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Remission | Remission defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI) | At 6 weeks following enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Compliance | Using modified Medication Adherence Rating Scale (MARS) questionnaire | Up to 12 weeks following enrollment |
| Change in C-reactive protein (CRP) between baseline and week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsey Albenberg, DO | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| 12 weeks |
| Change in erythrocyte sedimentation rate (ESR) between baseline and week 12 | 12 weeks |
| Change in fecal calprotectin (FCP) between baseline and week 12 | 12 weeks |
| Microbial composition of the gastrointestinal tract | Change in the microbial composition of the stool and rectum from baseline to 12 weeks. | 12 weeks |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |