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

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

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.

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.