Predicting Response to Standardized Pediatric Colitis Therapy
Status:
Completed
Trial end date:
2018-04-30
Target enrollment:
Participant gender:
Summary
This is a multi-center, open-label study to determine the safety and effectiveness (how well
it works) of two standardized treatments called "mesalamine" (Pentasa®) and "prednisone" in
children with newly diagnosed Ulcerative Colitis (UC). Standardized treatments are types of
treatments agreed upon and used by many qualified doctors. The medications being used in this
study are considered "standard of care". 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. 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 response and remission (free of symptoms) 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.
Phase:
Phase 4
Details
Lead Sponsor:
Connecticut Children's Medical Center
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)