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Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial - Trial NCT06216899

Access comprehensive clinical trial information for NCT06216899 through Pure Global AI's free database. This phase not specified trial is sponsored by Seattle Children's Hospital and is currently Not yet recruiting. The study focuses on Crohn Disease. Target enrollment is 60 participants.

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NCT06216899
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Trial Details
ClinicalTrials.gov โ€ข NCT06216899
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Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial

Study Focus

Crohn Disease

Whole-food based smoothie

Interventional

other

Sponsor & Location

Seattle Children's Hospital

Timeline & Enrollment

N/A

Mar 01, 2024

Jan 10, 2027

60 participants

Primary Outcome

Tolerance- Ability to remain on prescribed nutritional therapy

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.

ICD-10 Classifications

Crohn disease, unspecified
Other Crohn disease
Crohn disease of large intestine
Crohn disease of small intestine
Crohn disease [regional enteritis]

Data Source

ClinicalTrials.gov

NCT06216899

Non-Device Trial