Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Crohn Disease
- Sponsor
- Seattle Children's Hospital
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Tolerance- Ability to remain on prescribed nutritional therapy
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief 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.
Investigators
Dale Lee
Associate Professor, Medical Director, Clinical Nutrition; Director of the Celiac Disease Program
Seattle Children's Hospital
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) ≥
- •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.
Outcomes
Primary Outcomes
Tolerance- Ability to remain on prescribed nutritional therapy
Time Frame: 4 and 8 weeks
Tolerance of therapy as measured by ability to continue prescribed nutritional therapy over 4-weeks and 8-weeks without deviation from protocol. Participants will meet with a study dietitian at week 2, week4, and week 8. Dietitians will evaluate caloric needs, specific deficits, and dietary limitations.
Secondary Outcomes
- Fecal Calprotectin reduction from baseline(4 and 8 weeks)
- Pediatric Crohn's Disease Activity Index (PCDAI) reduction from baseline(4 and 8 weeks)