Reverse Engineering of Exclusive Enteral Nutrition (RE-EEN)
Primary Purpose
Crohn Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutritional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring Exclusive Enteral Nutrition, Nutrition, Diet, Inflammatory Bowel Disease
Eligibility Criteria
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
Sites / Locations
- Seattle Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Whole-foods based smoothie as nutritional therapy
Outcomes
Primary Outcome Measures
Fecal calprotectin <250 micrograms/gram
surrogate marker of intestinal inflammation
Secondary Outcome Measures
Quality of life as measured by IMPACT III Questionnaire
validated quality of life measure for pediatric inflammatory bowel disease
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03508193
Brief Title
Reverse Engineering of Exclusive Enteral Nutrition
Acronym
RE-EEN
Official Title
Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 4, 2017 (Actual)
Primary Completion Date
January 5, 2022 (Actual)
Study Completion Date
January 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dale Lee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Exclusive Enteral Nutrition, Nutrition, Diet, Inflammatory Bowel Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Whole-foods based smoothie as nutritional therapy
Intervention Type
Other
Intervention Name(s)
Nutritional therapy
Intervention Description
Whole-foods based smoothie designed to emulate formulas used in EEN
Primary Outcome Measure Information:
Title
Fecal calprotectin <250 micrograms/gram
Description
surrogate marker of intestinal inflammation
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Quality of life as measured by IMPACT III Questionnaire
Description
validated quality of life measure for pediatric inflammatory bowel disease
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale Y Lee, MD
Organizational Affiliation
Seattle Children's Hospital and The University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not Discussed
Citations:
PubMed Identifier
16162683
Citation
Johnson T, Macdonald S, Hill SM, Thomas A, Murphy MS. Treatment of active Crohn's disease in children using partial enteral nutrition with liquid formula: a randomised controlled trial. Gut. 2006 Mar;55(3):356-61. doi: 10.1136/gut.2004.062554. Epub 2005 Sep 14.
Results Reference
background
PubMed Identifier
25970545
Citation
Lee D, Baldassano RN, Otley AR, Albenberg L, Griffiths AM, Compher C, Chen EZ, Li H, Gilroy E, Nessel L, Grant A, Chehoud C, Bushman FD, Wu GD, Lewis JD. Comparative Effectiveness of Nutritional and Biological Therapy in North American Children with Active Crohn's Disease. Inflamm Bowel Dis. 2015 Aug;21(8):1786-93. doi: 10.1097/MIB.0000000000000426.
Results Reference
background
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Reverse Engineering of Exclusive Enteral Nutrition
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