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

Launched by SEATTLE CHILDREN'S HOSPITAL · Jan 17, 2024

Keywords

ClinConnect Summary

This clinical trial, called Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN), is looking to understand how well two different types of nutrition work for children and young adults with Crohn's disease, a condition that affects the digestive system. The study will involve 60 participants aged 8 to 21 who have recently been diagnosed with Crohn's disease. Some participants will receive a standard nutritional formula, while others will be guided to make a smoothie using whole foods. The study will last 8 weeks, during which researchers will check how well each type of nutrition is tolerated, how it affects overall health, the bacteria in their stool, and their quality of life.

To join the study, participants need to be between 8 and 21 years old and have a recent diagnosis of Crohn's disease. They should have signs of inflammation, which can be measured through blood tests or stool samples. However, those who have had surgery for Crohn's disease, have certain types of severe symptoms, or have recently used specific medications will not be eligible. Participants can expect to receive all the necessary ingredients and guidance for making the smoothies if they are in that group, and support throughout the trial. This study aims to find out if a whole-food-based approach can be as effective as traditional formulas in managing Crohn's disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.