Predicting Response to Standardized Pediatric Colitis Therapy (PROTECT)
Study Design: Interventional
Conditions: Colitis, Colitis, Ulcerative, Gastrointestinal Diseases
Duration: July 2012 – June 2017
# Recruitment Centers: 27
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Access to samples for Predicting Response to Standardized Pediatric Colitis Therapy (PROTECT) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Clinical Trials URL: http://www.clinicaltrials.gov/show/NCT01536535
This is a multi-center, open-label study to determine the safety and effectiveness of two standardized treatments called "mesalamine" (Pentasa®) and "prednisone" in children with newly diagnosed ulcerative colitis. The medications being used in this study are considered "standard of care", but currently the ways in which these medicines are used (doses, frequency of dosing) may vary from site to site. This study will determine response to a standardized way of giving these medicines.
This study will also identify biomarkers for ulcerative colitis. Collecting response and remission information on these standardized treatments and 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.
The objective of this study are to determine a standardized way of administering these medications, and to identify biomarkers for ulcerative colitis in order to create treatment models.
Primary Outcome Measures: Corticosteroid free remission
- Patients must be between the ages of 4 and 17, weigh 15 or more kg, and be recently diagnosed with ulcerative colitis in order to be included in the study.
- Patients younger than 4 or older than 17, who present with evidence of enteric infection, recent or current use of certain medications, or who have a history of some chronic illnesses are excluded from the study.
This study is ongoing, but not recruiting participants.