Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
NCT ID: NCT06216899
Last Updated: 2025-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-03-11
2030-01-10
Brief Summary
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Participants will be provided either commercial formula or guided on the preparation of the home-blended smoothie. These participants will be given a specific recipe, blender, and be provided the food components to the smoothie. The study will total 8 weeks and will assess tolerance, clinical outcomes, stool microbiome, and quality of life.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Smoothie
In the smoothie arm, you will be provided instructions, a blender, and food components to prepare the smoothie at home.
Whole-food based smoothie
The smoothies will be based upon the concept of reverse-engineering of exclusive enteral nutrition and provide 100% of calculated caloric needs for weeks 0-4. At week 4, select foods will be introduced to provide up to 20% of daily caloric needs.
Formula
In the formula arm, you will be given conventional formula as per the direction of the gastroenterology team along with our dieticians.
Formula
Conventional formula (Boost, Ensure, Modulen) as per the direction of their primary Gastroenterology team to provide 100% of calculated caloric needs for weeks 0-4. At week 4, select foods will be introduced to provide up to 20% of daily caloric needs.
Interventions
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Whole-food based smoothie
The smoothies will be based upon the concept of reverse-engineering of exclusive enteral nutrition and provide 100% of calculated caloric needs for weeks 0-4. At week 4, select foods will be introduced to provide up to 20% of daily caloric needs.
Formula
Conventional formula (Boost, Ensure, Modulen) as per the direction of their primary Gastroenterology team to provide 100% of calculated caloric needs for weeks 0-4. At week 4, select foods will be introduced to provide up to 20% of daily caloric needs.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Crohn's disease within 24 months
* Elevation in objective inflammatory markers at enrollment: C-reactive protein (CRP), ESR, or fecal calprotectin
* 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
* Perianal disease as part of Crohn's disease phenotype.
* Recent use of:
* corticosteroids (within 4 weeks),
* dose adjustment of immunomodulator (within 8 week)
* azathioprine 4 weeks prior to study final visit (week 8)
* start or adjust methotrexate 3 weeks prior to final study visit.
* Prior use of biological medication
* Prior treatment with EEN or other dietary therapy for Crohn's disease.
* 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.
8 Years
21 Years
ALL
No
Sponsors
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Children's Hospital of Philadelphia
OTHER
Dalhousie University
OTHER
Seattle Children's Hospital
OTHER
Responsible Party
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Dale Lee
Associate Professor, Medical Director, Clinical Nutrition; Director of the Celiac Disease Program
Principal Investigators
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Dale Lee, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital, University of Washington
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Seattle Children's Hospital
Seattle, Washington, United States
Izaak Walton Killam Health Centre
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00004459
Identifier Type: -
Identifier Source: org_study_id
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