Reverse Engineering of Exclusive Enteral Nutrition
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 8 - 21 |
| Updated: | 4/27/2018 |
| Start Date: | November 1, 2017 |
| End Date: | December 2018 |
| Contact: | Dale Lee, MD |
| Email: | dale.lee@seattlechildrens.org |
| Phone: | 206-987-2521 |
Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease
This will be an open label, pilot study over 8 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.
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.
Inclusion Criteria:
1. Age 8 -21 years old
2. Diagnosis of Crohn's disease within 4 weeks of study entry
3. Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI)
≥10.
4. Participant capable of giving informed consent, or if a minor the parent/guardian is
capable of giving informed consent
Exclusion Criteria:
1. History of surgery for Crohn's disease
2. Perianal disease as part of Crohn's disease phenotype
3. Prior treatment with EEN or the specific carbohydrate for Crohn's disease
4. Prior treatment with any immunosuppressive medication (corticosteroids, anti-TNF-alpha
agent, azathioprine, methotrexate, etc.)
5. Prior treatment with antibiotics for Crohn's disease
6. Known allergies to any of the food components in the smoothie
7. Admission to hospital due to severity of Crohn's disease and associated symptoms
8. Unwillingness to provide informed consent
We found this trial at
1
site
4800 Sand Point Way NE
Seattle, Washington 98105
Seattle, Washington 98105
(206) 987-2000
Phone: 206-987-2521
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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