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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
Sponsor:
Information provided by (Responsible Party):
Dale Lee, Seattle Children's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Crohn Disease Other: Nutritional therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Whole-foods based smoothie as nutritional therapy
 Other: Nutritional therapy
Whole-foods based smoothie designed to emulate formulas used in EEN


Outcome Measures
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Primary Outcome Measures :
  1. Fecal calprotectin <250 micrograms/gram [ Time Frame: 4 weeks ]
    surrogate marker of intestinal inflammation


Secondary Outcome Measures :
  1. Quality of life as measured by IMPACT III Questionnaire [ Time Frame: 4 weeks ]
    validated quality of life measure for pediatric inflammatory bowel disease


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Mason E Nuding 206-987-0055 mason.nuding@seattlechildrens.org
Contact: Clinical Research Coordinator 206-987-2521 giresearch@seattlechildrens.org

Locations
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United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Mason E Nuding    206-987-0055    mason.nuding@seattlechildrens.org   
Contact: Clinical Research Coordinator    206-987-2521    giresearch@seattlechidlrens.org   
Principal Investigator: Dale Y Lee, MD         
Sub-Investigator: David L Suskind, MD         
Sponsors and Collaborators
Dale Lee
Investigators
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Principal Investigator: Dale Y Lee, MD Seattle Children's Hospital and The University of Washington
More Information
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Publications:

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Responsible Party: Dale Lee, Associate Professor of Pediatrics, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03508193    
Other Study ID Numbers: STUDY00000619
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not Discussed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dale Lee, Seattle Children's Hospital:
EEN
Nutrition
Diet
IBD
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases