Evaluating the Tolerability and Efficacy of a Whole Food Home-Blended Formula as Exclusive Enteral Nutrition Therapy for pediatric Crohn's Disease. - Kenneth Rainin Foundation

Evaluating the Tolerability and Efficacy of a Whole Food Home-Blended Formula as Exclusive Enteral Nutrition Therapy for pediatric Crohn’s Disease.

Diet plays a unique role in Crohn’s disease (CD) pathogenesis and therapy. In pediatric CD, commercial formulas used as exclusive enteral nutrition (EEN) are effective at inducing both clinical and biochemical remission. This study assesses the impact of a whole-food blended smoothie as EEN on CD activity and the intestinal microbiome.

The primary aims of this study are: 1) To evaluate the tolerability of a whole-food based smoothie as EEN therapy, and 2) To evaluate the ability of a whole-food based smoothie to induce remission of active pediatric CD. 

This study will compare the tolerability and efficacy of conventional formula EEN and whole-food blended smoothie EEN by enrolling a total of 40 participants with newly diagnosed pediatric 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, Vitamix blender and be provided the food components to the smoothie. The study will total 8 weeks and will assess tolerance, clinical outcomes, the stool microbiome and quality of life.