Predicting Responses to Standardized Pediatric Colitis Therapy
The mission of the PROTECT Study is to provide a better understanding of how children newly diagnosed with ulcerative colitis (UC) respond to mesalamine and prednisone (corticosteroid), the standard initial therapies used to treat this disorder. PROTECT brings together the experience and resources of 25 highly specialized sites in North America that treat children with UC and the National Institutes of Health (NIH) through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) which is supporting this study. The PROTECT study is performed in collaboration with the Crohn’s and Colitis Foundation of America (CCFA) using its Pediatric Research Organization for Kids with Intestinal Inflammatory Diseases (PRO-KIIDS) Network.

Over a period of 5 years PROTECT will prospectively study the course of 430 children newly diagnosed with UC who are treated with standardized care. Biospecimens (blood, stool, colonic biopsy tissue) will be obtained and used to better understand the effects of genetics, mechanisms of inflammation, Vitamin D, and the bacteria contained in the stool (microbiome) on clinical outcomes.

This website is maintained for PROTECT participants, PROTECT investigators, health professionals, and the general public.
Acronym: PROTECT
Clinical Centers: 24
Participants: 430
Funding: Univ Connecticut, NIDDK
Study Design: Multicenter open-label clinical trial