Reverse Engineering of Exclusive Enteral Nutrition (RE-EEN)
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|ClinicalTrials.gov Identifier: NCT03508193|
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : November 4, 2020
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:
- To develop a whole-food based smoothie, based on principles of the specific carbohydrate diet, that is comparable in macronutrients and micronutrients to formulas used for exclusive enteral nutritional (EEN) therapy in Crohn's disease.
- To evaluate the ability of a whole-food based smoothie to induce remission of active Crohn's disease.
- To evaluate changes to the intestinal microbiome in healthy individuals consuming a whole-food based smoothie diet.
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Other: Nutritional therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease|
|Actual Study Start Date :||November 4, 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Whole-foods based smoothie as nutritional therapy
Other: Nutritional therapy
Whole-foods based smoothie designed to emulate formulas used in EEN
- Fecal calprotectin <250 micrograms/gram [ Time Frame: 4 weeks ]surrogate marker of intestinal inflammation
- Quality of life as measured by IMPACT III Questionnaire [ Time Frame: 4 weeks ]validated quality of life measure for pediatric inflammatory bowel disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508193
|Contact: Mason E Nudingemail@example.com|
|Contact: Clinical Research Coordinatorfirstname.lastname@example.org|
|United States, Washington|
|Seattle Children's Hospital||Recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Mason E Nuding 206-987-0055 email@example.com|
|Contact: Clinical Research Coordinator 206-987-2521 firstname.lastname@example.org|
|Principal Investigator: Dale Y Lee, MD|
|Sub-Investigator: David L Suskind, MD|
|Principal Investigator:||Dale Y Lee, MD||Seattle Children's Hospital and The University of Washington|