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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
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.
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGSeattle Children's Hospital
Seattle, Washington, United States
RECRUITINGIzaak Walton Killam Health Centre
Halifax, Nova Scotia, Canada
NOT_YET_RECRUITINGTolerance- Ability to remain on prescribed nutritional therapy
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.
Time frame: 4 and 8 weeks
Fecal Calprotectin reduction from baseline
Fecal calprotectin (FCP) level \<250 μg/gram
Time frame: 4 and 8 weeks
Pediatric Crohn's Disease Activity Index (PCDAI) reduction from baseline
Pediatric Crohn's Disease Activity Index (PCDAI) score \<10 (clinical remission). PCDAI will be calculated at each visit. The total score is calculated from assessments in 11 sections. Minimum score 0. Maximum score 100. A lower score is better. History (recall 1 week) * Abdominal pain * Stools * Patient functioning * General well-being Physical Examination * Weight * Height * Abdomen * Peri-rectal disease * Extra-intestinal manifestations Laboratory * Hematocrit (%) * Erythrocyte sedimentation rate (ESR) (mm/hr) * Albumin (g/L)
Time frame: 4 and 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.