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Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial

NCT06216899 · Seattle Children's Hospital
In plain English

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About this study
This study will compare the tolerability and efficacy of conventional formula Exclusive Enteral Nutrition (EEN) and whole-food blended smoothie EEN by enrolling a total of 60 participants with newly diagnosed pediatric Crohn's disease (CD). 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.
Eligibility criteria
Inclusion Criteria: * Age 8 -21 years old. * 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: * History of surgery for Crohn's disease. * 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.
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2024-03-11
Estimated completion: 2030-01-10
Last updated: 2025-06-12
Interventions
Other: Whole-food based smoothieOther: Formula
Primary outcomes
  • Tolerance- Ability to remain on prescribed nutritional therapy (4 and 8 weeks)
Sponsor
Seattle Children's Hospital · other
With: Children's Hospital of Philadelphia, Dalhousie University
Contacts & investigators
ContactMason E Nuding · contact · mason.nuding@seattlechildrens.org · 206-987-0055
InvestigatorDale Lee, MD, MSCE · principal_investigator, Seattle Children's Hospital, University of Washington
All locations (3)
Children's Hospital of PhiladelphiaNot Yet Recruiting
Philadelphia, Pennsylvania, United States
Seattle Children's HospitalRecruiting
Seattle, Washington, United States
Izaak Walton Killam Health CentreNot Yet Recruiting
Halifax, Nova Scotia, Canada
Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial · TrialPath