A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients with Cystic Fibrosis Treated with Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors
The purpose of this study is to determine the number of patients affected by FC and to learn more about what might cause it, including use of pancreatic enzyme supplements. Participants of this study have been diagnosed with Cystic Fibrosis with the possibility of having a condition called Fibrosing Colonopathy (FC). FC is a health problem that affects the colon and is seen almost only in patients with Cystic Fibrosis. FC is a painful swelling, shortening, and fibrosis (scarring) of the colon. Patients with FC may have abdominal pain, diarrhea, rectal bleeding, and in some cases, partial or complete blockage of their colon. The information collected will include all medical information associated with suspected cases of FC, including information about medicines that have been prescribed and the results of any tests that were performed to diagnose this condition. This information will be entered into a secure database. This information will be shared with the Study researchers, governmental agencies, the companies making the pancreatic enzyme supplements and other people working on the study.
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