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)


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Trial ID: NCT01652157


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)

Stanford Investigator(s)


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


biological: CREON

biological: ZENPEP

biological: ULTRESA

biological: PANCREAZE

biological: other non-sponsor pancreatic enzyme replacement therapy

other: No pancreatic enzyme replacement therapy

biological: PERTZYE


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Carlos Milla
650) 723-8325, (650) 736-9824