Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
Recruiting now · Not applicable
Conditions studied: Crohn Disease
In brief
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 facts
- Study ID
- NCT06216899
- Run by
- Seattle Children's Hospital
- People needed
- 60
- Starts
- 2024-03-11
- Expected to finish
- 2030-01-10
- Last updated by the study team
- 2025-06-12
Who can join
Age: 8 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 8 -21 years old.
- Diagnosis of Crohn's disease within 24 months
- Elevation in objective inflammatory markers at enrollment: C-reactive protein (CRP), ESR, or fecal calprotectin
- Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10.
- Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent.
You may not qualify if…
- History of surgery for Crohn's disease.
- Perianal disease as part of Crohn's disease phenotype.
- Recent use of:
- corticosteroids (within 4 weeks),
- dose adjustment of immunomodulator (within 8 week)
- azathioprine 4 weeks prior to study final visit (week 8)
- start or adjust methotrexate 3 weeks prior to final study visit.
- Prior use of biological medication
- Prior treatment with EEN or other dietary therapy for Crohn's disease.
- Prior treatment with antibiotics for Crohn's disease.
- Known allergies to any of the food components in the smoothie.
- Admission to hospital due to severity of Crohn's disease and associated symptoms.
- Unwillingness to provide informed consent.
Where it is running
- Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Izaak Walton Killam Health Centre — Halifax, Nova Scotia, Canada
Full record on ClinicalTrials.gov
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