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#



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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

Ages Eligible for Study: 0 Months to 99 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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:
  1. - None


Carlos Milla
Zachary M. Sellers, MD, PhD

Contact us to find out if this trial is right for you.


Carlos Milla
650) 723-8325, (650) 736-9824