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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Seattle Children's Hospital
Study ID
NCT06216899
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Whole-food based smoothie — OTHER
    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.
  • Formula — OTHER
    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.

Study Details

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 Dates

Start date
Mar 11, 2024
Status verified
Jun 2025
Primary completion
Apr 1, 2027
Completion
Jan 10, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Smoothie
    In the smoothie arm, you will be provided instructions, a blender, and food components to prepare the smoothie at home.
  • Active Comparator: Formula
    In the formula arm, you will be given conventional formula as per the direction of the gastroenterology team along with our dieticians.

Primary Outcome Measure

Tolerance- Ability to remain on prescribed nutritional therapy [ Time Frame: 4 and 8 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19146
Clarice Cook
[email protected]
445-942-7445
Lindsey Albenberg, DO (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
Danny Gagucas
[email protected]
206-987-1062
Dale Lee, MD, MSCE (PRINCIPAL_INVESTIGATOR)
David Suskind, MD (SUB_INVESTIGATOR)
Betty Zheng, MD (SUB_INVESTIGATOR)
Ghassan Wahbeh, MD (SUB_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Children's Hospital of Philadelphia· Philadelphia, PASeattle Children's Hospital· Seattle, WA

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