Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:36 PM
Study NCT ID:
NCT03508193
Status:
COMPLETED
Last Update Posted:
2022-11-21
First Post:
2018-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reverse Engineering of Exclusive Enteral Nutrition
Sponsor:
Dale Lee
Organization:
Study Overview
Official Title:
Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RE-EEN
Brief Summary:
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:
1. 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.
2. To evaluate the ability of a whole-food based smoothie to induce remission of active Crohn's disease.
3. To evaluate changes to the intestinal microbiome in healthy individuals consuming a whole-food based smoothie diet.
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:
1. 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.
2. To evaluate the ability of a whole-food based smoothie to induce remission of active Crohn's disease.
3. To evaluate changes to the intestinal microbiome in healthy individuals consuming a whole-food based smoothie diet.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: