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Diagnostic Value of Fecal Calprotectin in Disorders of the Upper Gastrointestinal Tract

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00920400
First received: June 12, 2009
Last updated: January 11, 2010
Last verified: January 2010
History of Changes
  Purpose

Fecal calprotectin is a very sensitive non-invasive inflammation marker in the detection of inflammatory bowel disease and, to a lesser degree, has also proven to be useful in adenomatous polyps, neoplasias, and infectious gastroenteritis. Elevated calprotectin levels can also be found in patients with lesion only in the upper gastrointestinal tract. However, the diagnostic value of calprotectin has never been tested in this setting. The aim of the study is therefore to determine the diagnostic value of fecal calprotectin in patients with diseases of the upper gastrointestinal tract.


Condition
Peptic Esophagitis
Peptic Ulcer
Functional Dyspepsia
Irritable Bowel Syndrome
Inflammatory Bowel Diseases

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Value of Fecal Calprotectin in Upper Gastrointestinal Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Biospecimen Retention:   Samples Without DNA

Biopsy samples (stomach, duodenum) will be stored by the Department of Pathology at the University Hospital Basel


Enrollment: 287
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

300 consecutive patients undergoing upper endoscopy at the Department of Gastroenterology & Hepatology at the University Hospital Basel

Criteria

Inclusion Criteria:

  • All patients referred for upper gastrointestinal endoscopy for any reason
  • Older than 18 years

Exclusion Criteria:

  • Patients who are not able to provide informed consent
  • Patients who are not able to provide a stool sample
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920400

Locations
Switzerland
Department of Gastroenterology & Hepatology
Basel, Basel-Stand, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christoph Beglinger, Prof. University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: Professor Christoph Beglinger, Head of Gastroenterology & Hepatology, University Hospital Basel
ClinicalTrials.gov Identifier: NCT00920400     History of Changes
Other Study ID Numbers: CALPROTECT
Study First Received: June 12, 2009
Last Updated: January 11, 2010
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Dyspepsia
Esophagitis
Esophagitis, Peptic
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Irritable Bowel Syndrome
Peptic Ulcer
Ulcer
 Signs and Symptoms, Digestive
Signs and Symptoms
Esophageal Diseases
Gastroenteritis
Colonic Diseases, Functional
Colonic Diseases
Duodenal Diseases
Stomach Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013