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

Description

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.

Conditions

Crohn Disease

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Study Overview

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Study Details

Study overview

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.

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

Condition
Crohn Disease
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19146

Seattle

Seattle Children's Hospital, Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

8 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Seattle Children's Hospital,

Dale Lee, MD, MSCE, PRINCIPAL_INVESTIGATOR, Seattle Children's Hospital, University of Washington

Study Record Dates

2027-01-10