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RECRUITING
NCT06216899
NA

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

Sponsor: Seattle Children's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

8 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-03-11

Completion Date

2030-01-10

Last Updated

2025-06-12

Healthy Volunteers

No

Conditions

Interventions

OTHER

Whole-food based smoothie

The smoothies will be based upon the concept of reverse-engineering of exclusive enteral nutrition and provide 100% of calculated caloric needs for weeks 0-4. At week 4, select foods will be introduced to provide up to 20% of daily caloric needs.

OTHER

Formula

Conventional formula (Boost, Ensure, Modulen) as per the direction of their primary Gastroenterology team to provide 100% of calculated caloric needs for weeks 0-4. At week 4, select foods will be introduced to provide up to 20% of daily caloric needs.

Locations (3)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Seattle Children's Hospital

Seattle, Washington, United States

Izaak Walton Killam Health Centre

Halifax, Nova Scotia, Canada