Value of Fecal Calprotectin

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. Identifier: NCT00577928
Recruitment Status : Completed
First Posted : December 20, 2007
Last Update Posted : August 10, 2015
Information provided by (Responsible Party):
Indiana University

Brief Summary:
For the main goal - the accuracy of calprotectin for the diagnosis of IBD - calprotectin levels will be compared between patients with and without a diagnosis of IBD and the sensitivity, specificity and accuracy will be determined. For the secondary aim - the correlation between calprotectin levels and disease activity - in patients with IBD selected from this cohort, we will determine the association between calprotectin levels and clinical IBD score, serological markers (WBC, Hgb, Platelets, ESR, CRP, Albumin), endoscopic (disease score, pathological activity) and radiological features (bowel wall thickening, enhancement, edema, mesenteric inflammation).

Condition or disease
Calprotectin Inflammatory Bowel Disease

Study Type : Observational
Actual Enrollment : 171 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Correlation of Fecal Calprotectin Level With the Clinical, Endoscopic, Histologic and Radiologic Activity in Inflammatory Bowel diseaseThe Value of Fecal Calprotectin for the Diagnosis and Assessment of Inflammatory Bowel Disease
Study Start Date : April 2006
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients who had calprotectin assays as part of their evaluations for lower gastrointestinal symptoms in the Division of Gastroenterology at IU within the last 12 months will be considered eligible for the study.

Inclusion Criteria:

  • Calprotectin assay at IU in last 12 months

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 identifier (NCT number): NCT00577928

United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Principal Investigator: Michael Chiorean, M.D. Indiana University

Responsible Party: Indiana University Identifier: NCT00577928     History of Changes
Other Study ID Numbers: 060362
IRB# 0603-62
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases