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

Last updated: June 9, 2025
Sponsor: Seattle Children's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Formula

Whole-food based smoothie

Clinical Study ID

NCT06216899
STUDY00004459
  • Ages 8-21
  • All Genders

Study 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 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

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 iscapable of giving informed consent.

Exclusion

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

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Formula
Phase:
Study Start date:
March 11, 2024
Estimated Completion Date:
January 10, 2030

Connect with a study center

  • Izaak Walton Killam Health Centre

    Halifax, Nova Scotia B3J 0C3
    Canada

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19146
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

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