Predicting Response to Standardized Pediatric Colitis Therapy: The PROTECT Study (11-320A)
Protocol ID
11-320A
Protocol Description
Ulcerative colitis is a condition that causes inflammation of the lining of the large intestine or colon. Inflammation means that the colon may be red, swollen, and sore. Ulcerative colitis may be associated with loose stools (diarrhea), blood in the stool, and abdominal cramps/pain.
The purpose of this study is to determine the safety and effectiveness of two standardized treatments called “mesalamine” (Pentasa®) and “prednisone” in children with newly diagnosed ulcerative colitis (UC). Currently the ways in which these medications are used (doses, frequency of dosing) may vary. This study will hopefully determine response to a standardized way of giving these medications.
This study will also identify bio-markers for ulcerative colitis. Biomarkers are things that doctors can find 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. Collecting symptom response and remission (disappearance) information in children receiving these standardized treatments and characterizing the “biomarkers” can possibly help doctors create a model, or plan to know which children with UC may respond quickly, or which children may develop complications.
Eligibility Criteria
Participants with new diagnosis of ulcerative colitis who are between the ages of 4 and 17 and weigh 15kg or more
Primary Investigator(s)
- James Markowitz, MD