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Primary: Nutritional therapy in the form of a whole-food based smoothie can be used to induce remission of active Crohn's disease.
Secondary: Consuming a whole foods based smoothie will result in measurable changes to the microbiome of individuals with Crohn's disease and healthy controls.
The specific aims of this proposal are:
This will be an open label, pilot study over 4 weeks in children with newly diagnosed Crohn's disease treated with a smoothie designed to emulate formulas used for exclusive enteral nutritional therapy. In place of formula, whole-foods based smoothie recipes and the food to create the smoothies will be given to each participant/family. The smoothies will be based upon the concept of reverse-engineering of exclusive enteral nutrition (RE-EEN). The smoothie recipes will involve whole foods that can be blenderized to liquid consistency. Similar to the formulas used for EEN, the smoothies will provide calories, protein, fat, and carbohydrates in a distribution to support growth and development.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Whole-foods based smoothie as nutritional therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional therapy | Other | Whole-foods based smoothie designed to emulate formulas used in EEN |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fecal calprotectin <250 micrograms/gram | surrogate marker of intestinal inflammation | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life as measured by IMPACT III Questionnaire | validated quality of life measure for pediatric inflammatory bowel disease | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dale Y Lee, MD | Seattle Children's Hospital and The University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16162683 | Background | Johnson T, Macdonald S, Hill SM, Thomas A, Murphy MS. Treatment of active Crohn's disease in children using partial enteral nutrition with liquid formula: a randomised controlled trial. Gut. 2006 Mar;55(3):356-61. doi: 10.1136/gut.2004.062554. Epub 2005 Sep 14. | |
| 25970545 | Background | Lee D, Baldassano RN, Otley AR, Albenberg L, Griffiths AM, Compher C, Chen EZ, Li H, Gilroy E, Nessel L, Grant A, Chehoud C, Bushman FD, Wu GD, Lewis JD. Comparative Effectiveness of Nutritional and Biological Therapy in North American Children with Active Crohn's Disease. Inflamm Bowel Dis. 2015 Aug;21(8):1786-93. doi: 10.1097/MIB.0000000000000426. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 25, 2026 | |
| Reset | Jun 18, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 25, 2026 | Jun 18, 2026 |
| 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 |
|---|---|
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 38558411 | Derived | Lee D, Braly K, Nuding M, Braly I, Hopp C, Twible H, Pope C, Hayden HS, Hoffman L, Zheng H, Wahbeh G, Suskind DL. Reverse-engineered exclusive enteral nutrition in pediatric Crohn's disease: A pilot trial. J Pediatr Gastroenterol Nutr. 2024 May;78(5):1135-1142. doi: 10.1002/jpn3.12196. Epub 2024 Apr 1. |