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Reverse Engineering of Exclusive Enteral Nutrition

NCT03508193 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-11-21

No results posted yet for this study

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.

Conditions

  • Crohn Disease

Interventions

OTHER

Nutritional therapy

Whole-foods based smoothie designed to emulate formulas used in EEN

Sponsors & Collaborators

  • Dale Lee

    lead OTHER

Principal Investigators

  • Dale Y Lee, MD · Seattle Children's Hospital and The University of Washington

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-04
Primary Completion
2022-01-05
Completion
2022-01-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03508193 on ClinicalTrials.gov