Status:
RECRUITING
Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
Children's Hospital of Philadelphia
Dalhousie University
Conditions:
Crohn Disease
Eligibility:
All Genders
8-21 years
Phase:
NA
Brief Summary
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 10 2030
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06216899
Start Date
March 11 2024
End Date
January 10 2030
Last Update
June 12 2025
Active Locations (3)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19146
2
Seattle Children's Hospital
Seattle, Washington, United States, 98105
3
Izaak Walton Killam Health Centre
Halifax, Nova Scotia, Canada, B3J 0C3