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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
| Dalhousie University | OTHER |
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This study will compare the tolerability and efficacy of conventional formula Exclusive Enteral Nutrition (EEN) and whole-food blended smoothie EEN by enrolling a total of 60 participants with newly diagnosed pediatric Crohn's disease (CD).
Participants will be provided either commercial formula or guided on the preparation of the home-blended smoothie. These participants will be given a specific recipe, blender, and be provided the food components to the smoothie. The study will total 8 weeks and will assess tolerance, clinical outcomes, stool microbiome, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smoothie | Experimental | In the smoothie arm, you will be provided instructions, a blender, and food components to prepare the smoothie at home. |
|
| Formula | Active Comparator | In the formula arm, you will be given conventional formula as per the direction of the gastroenterology team along with our dieticians. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-food based smoothie | Other | The smoothies will be based upon the concept of reverse-engineering of exclusive enteral nutrition and provide 100% of calculated caloric needs for weeks 0-4. At week 4, select foods will be introduced to provide up to 20% of daily caloric needs. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance- Ability to remain on prescribed nutritional therapy | Tolerance of therapy as measured by ability to continue prescribed nutritional therapy over 4-weeks and 8-weeks without deviation from protocol. Participants will meet with a study dietitian at week 2, week4, and week 8. Dietitians will evaluate caloric needs, specific deficits, and dietary limitations. | 4 and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal Calprotectin reduction from baseline | Fecal calprotectin (FCP) level <250 μg/gram | 4 and 8 weeks |
| Pediatric Crohn's Disease Activity Index (PCDAI) reduction from baseline | Pediatric Crohn's Disease Activity Index (PCDAI) score <10 (clinical remission). PCDAI will be calculated at each visit. The total score is calculated from assessments in 11 sections. Minimum score 0. Maximum score 100. A lower score is better. History (recall 1 week)
Physical Examination
Laboratory
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mason E Nuding | Contact | 206-987-0055 | mason.nuding@seattlechildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Dale Lee, MD, MSCE | Seattle Children's Hospital, University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Not yet recruiting | Philadelphia | Pennsylvania | 19146 | United States |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D005526 | Food, Formulated |
| ID | Term |
|---|---|
| D019648 | Foods, Specialized |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Formula | Other | Conventional formula (Boost, Ensure, Modulen) as per the direction of their primary Gastroenterology team to provide 100% of calculated caloric needs for weeks 0-4. At week 4, select foods will be introduced to provide up to 20% of daily caloric needs. |
|
| 4 and 8 weeks |
| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
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| Izaak Walton Killam Health Centre | Not yet recruiting | Halifax | Nova Scotia | B3J 0C3 | Canada |
|
| D019602 |
| Food and Beverages |