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

Sponsored by Seattle Children's Hospital

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.

Where this study is enrolling (2)

Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.