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)

Summary

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.

Conditions

• Fibrosing Colonopathy

Interventions

BIOLOGICAL

ULTRESA

pancreatic enzyme replacement therapy

BIOLOGICAL

PANCREAZE

pancreatic enzyme replacement therapy

BIOLOGICAL

CREON

pancreatic enzyme replacement therapy

BIOLOGICAL

ZENPEP

pancreatic enzyme replacement therapy

BIOLOGICAL

other non-sponsor pancreatic enzyme replacement therapy

pancreatic enzyme replacement therapy

BIOLOGICAL

PERTZYE

pancreatic enzyme replacement therapy

OTHER

No pancreatic enzyme replacement therapy

Cystic fibrosis patients in the cystic fibrosis registry not receiving any pancreatic enzyme replacement therapy (approximately 10%)

Sponsors & Collaborators

• Cystic Fibrosis Foundation

  collaborator OTHER

• Digestive Care, Inc.

  collaborator INDUSTRY

• Nestle Health Science

  collaborator INDUSTRY

• VIVUS LLC

  collaborator INDUSTRY

• AbbVie

  lead INDUSTRY

Principal Investigators

• Craig Peterson · VIVUS LLC

Eligibility

Min Age

0 Months

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2020-04-08

Completion

2020-04-08

FDA Drug

Yes

Countries

• United States

Study Locations