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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
This study is tracking the incidence of fibrosing colonopathy — a rare complication in CF patients that use pancreatic enzymes.
All patients who are participating in the CF Foundation Patient Registry and develop signs and symptoms of fibrosing colonopathy and be in this study.
Fibrosing colonopathy or “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.
It is not known exactly what causes FC. 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. The first reports of FC were in the 1990s and were linked with the use of high-dose pancreatic enzyme supplements. Dosing guidelines for pancreatic enzyme supplements were then put in place, and use of high-dose supplements was stopped. FC still occurs rarely in some patients with cystic fibrosis, so it is important to monitor the use of pancreatic enzyme supplements and other standard treatments in patients with cystic fibrosis to learn more about FC. The U.S. Food and Drug Administration (FDA) has asked the manufacturers of pancreatic enzyme supplements to study how often FC occurs in cystic fibrosis patients and to see if there may be a link between taking pancreatic enzyme medications and developing FC.
Trial Name: 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
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