Ulcerative Colitis PROTECT Study – Phase IV

Predicting Response to Standardized Pediatric Colitis Therapy: The PROTECT Study

Protocol Description

Through the multi-center PROTECT study, researchers hope to gain a better understanding of how children newly diagnosed with ulcerative colitis (UC) respond to mesalamine and prednisone (a corticosteroid), the standard initial therapies used to treat this disorder, which is a form of chronic inflammatory bowel disease. The study will also identify biomarkers – clues found in blood, stool, or bowel tissue – that indicate how much inflammation there is in the bowel, how the inflammation is produced, and whether the inflammation is responding to treatment. This information may help researchers create a model, or plan, to help determine which children with UC may respond quickly, or which children may develop complications. Supported by the National Institutes of Health, the PROTECT study is being done in collaboration with the Crohn’s and Colitis Foundation of America, and its Pediatric Research Organization for Kids with Intestinal Inflammatory Diseases Network (PRO-KIIDS).
Study Level – Phase IV

Eligibility Criteria

Patients of both genders through age 17, who have been diagnosed with ulcerative colitis, are eligible for inclusion.
Boys: Ages 4 through 17
Girls: Ages 4 through 17

Participants will be treated by their own physicians, working in collaboration with the study team. Treatment will be started with either mesalamine (Pentasa®) or prednisone, with medications administered in standard doses based on weight. If prednisone is initially used, it will be gradually decreased after an initial dosing period of 3 weeks, providing there is improvement in the UC, and mesalamine will be started. Completion of study-specific questionnaires will be required, and researchers will follow up by telephone at specific intervals.
Visits: Every 3 months in first year, and at least 2 times annually thereafter
Duration: Up to 5 years

Status: Open for Enrollment

Source of Support
National Institute of Diabetes and Digestive and Kidney Diseases

Additional Information
Study description at the National Institutes of Health
PROTECT Study Website

Primary Investigator(s)

David J. Keljo, MD, PhD

Contact Information

For more information about the study or enrollment, please contact:
Amy Bookser, RN

Last Update
June 24, 2014
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Last Update
June 24, 2014