Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at their regular clinical care visits over a 10-year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information.
Official Title
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 CF-FC Study)
Eligibility Criteria
- The inclusion criteria for enrollment in the Base Study Population
- * Diagnosed with cystic fibrosis,* Enrolled in the Cystic Fibrosis Patient Registry* Receiving medical care at a Cystic Fibrosis Foundation-accredited care center providing data to the Cystic Fibrosis Patient Registry
- * None
Contact us to find out if this trial is right for you.
Contact
Carlos Milla
650) 723-8325, (650) 736-9824
View on ClinicalTrials.gov
