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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00920400
First Posted: June 15, 2009
Last Update Posted: January 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Basel, Switzerland
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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

Responsible Party: Professor Christoph Beglinger, Head of Gastroenterology & Hepatology, University Hospital Basel
ClinicalTrials.gov Identifier: NCT00920400     History of Changes
Other Study ID Numbers: CALPROTECT
First Submitted: June 12, 2009
First Posted: June 15, 2009
Last Update Posted: January 12, 2010
Last Verified: January 2010

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