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Fecal Calprotectin in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00863694
Recruitment Status : Completed
First Posted : March 18, 2009
Last Update Posted : December 13, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Elevated fecal calprotectin is a biomarker for intestinal inflammation in cystic fibrosis

Condition or disease
Cystic Fibrosis

Study Design

Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fecal Calprotectin in Cystic Fibrosis
Study Start Date : February 2009
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. collection of 150 stool specimens [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
stool

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: December 2013

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

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