Fecal Calprotectin in Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steve Werlin, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00863694
First received: March 16, 2009
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

Elevated fecal calprotectin is a biomarker for intestinal inflammation in cystic fibrosis


Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fecal Calprotectin in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • collection of 150 stool specimens [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

stool


Enrollment: 106
Study Start Date: February 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients attending the cystic fibrosis clinics at the Children's Hospital of Wisconsin and Froedtert Hospital

Criteria

Inclusion Criteria:

  • All patients

Exclusion Criteria:

  • Informed consent/assent not obtained
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863694

Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Steven Werlin, MD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Steve Werlin, Professor of Pediatric Gastroenterology, M.D., Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00863694     History of Changes
Other Study ID Numbers: calpro
Study First Received: March 16, 2009
Last Updated: December 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
cystic fibrosis
calprotectin
elastase

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014