Actively Recruiting
Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
Led by Seattle Children's Hospital · Updated on 2025-06-12
60
Participants Needed
3
Research Sites
304 weeks
Total Duration
On this page
Sponsors
S
Seattle Children's Hospital
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 8 to 21 years old
- Diagnosis of Crohn's disease within the past 24 months
- Elevated inflammatory markers such as C-reactive protein (CRP), ESR, or fecal calprotectin at enrollment
- Active Crohn's disease with Pediatric Crohn's Disease Activity Index (PCDAI) score of 10 or higher
- Participant or parent/guardian able to provide informed consent
You will not qualify if you...
- History of surgery for Crohn's disease
- Perianal disease related to Crohn's disease
- Recent use of corticosteroids within 4 weeks
- Dose adjustment of immunomodulators within 8 weeks
- Use of azathioprine within 4 weeks prior to final study visit
- Start or adjustment of methotrexate within 3 weeks prior to final study visit
- Prior use of biological medication for Crohn's disease
- Previous treatment with Exclusive Enteral Nutrition or other dietary therapy for Crohn's disease
- Previous treatment with antibiotics for Crohn's disease
- Known allergies to any ingredients in the smoothie
- Hospitalization due to severe Crohn's disease symptoms
- Unwillingness to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19146
Not Yet Recruiting
2
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
3
Izaak Walton Killam Health Centre
Halifax, Nova Scotia, Canada, B3J 0C3
Not Yet Recruiting
Research Team
M
Mason E Nuding
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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