Reverse Engineering of Exclusive Enteral Nutrition

Study Overview
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Brief Summary
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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: 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.

Detailed Description
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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.

Official Title
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Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Other: Nutritional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 8 -21 years old Diagnosis of Crohn's disease within 4 weeks of study entry Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10. Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent Exclusion Criteria: History of surgery for Crohn's disease Perianal disease as part of Crohn's disease phenotype Prior treatment with EEN or the specific carbohydrate for Crohn's disease Prior treatment with any immunosuppressive medication (corticosteroids, anti-TNF-alpha agent, azathioprine, methotrexate, etc.) Prior treatment with antibiotics for Crohn's disease Known allergies to any of the food components in the smoothie Admission to hospital due to severity of Crohn's disease and associated symptoms Unwillingness to provide informed consent

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Whole-foods based smoothie as nutritional therapy | Other: Nutritional therapy<br>* Whole-foods based smoothie designed to emulate formulas used in EEN<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal calprotectin <250 micrograms/gram | surrogate marker of intestinal inflammation | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exclusive Enteral Nutrition, Nutrition, Diet, Inflammatory Bowel Disease