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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)
Not Recruiting
Trial ID: NCT01652157
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
Inclusion 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
Exclusion Criteria:
* None
Intervention(s):
biological: CREON
biological: ZENPEP
biological: ULTRESA
biological: PANCREAZE
biological: other non-sponsor pancreatic enzyme replacement therapy
other: No pancreatic enzyme replacement therapy
biological: PERTZYE
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Carlos Milla
650) 723-8325, (650) 736-9824