RecruitingNot ApplicableNCT06216899

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


Sponsor

Seattle Children's Hospital

Enrollment

60 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 8 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a dietary treatment for children and young adults with active Crohn's disease — a chronic condition causing inflammation in the digestive tract. Called exclusive enteral nutrition (EEN), this approach involves replacing all regular food with a specially formulated liquid diet for a period of time, which can calm gut inflammation. This study is testing a smoothie-based version to make it more acceptable and practical for young patients. **You may be eligible if...** - You are 8 to 21 years old - You have been diagnosed with Crohn's disease within the past 24 months - Your Crohn's disease is currently active (based on a standard pediatric activity score of 10 or above) - You have elevated inflammatory markers in your blood or stool - You (or a parent/guardian if you are a minor) can give informed consent **You may NOT be eligible if...** - You have had surgery for Crohn's disease - You have perianal Crohn's disease (disease around the anal region) - You have recently used steroids, or recently changed your immunosuppressant dose - You have previously received biologic medications, exclusive enteral nutrition, dietary therapy, or antibiotics specifically for Crohn's - You are currently hospitalized due to the severity of your disease - You have known food allergies to any smoothie ingredients - You are unwilling to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERWhole-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.

OTHERFormula

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

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NCT06216899


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