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Fecal Calprotectin in Cystic Fibrosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Steve Werlin, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00863694
First received: March 16, 2009
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  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:

U.S. FDA Resources

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


Estimated Enrollment: 150
Study Start Date: February 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 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
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: May 14, 2012
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 May 19, 2013