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NCT00577928 Clinical Trial

Value of Fecal Calprotectin

Inflammatory Bowel Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00577928
Other study ID # 060362
Secondary ID IRB# 0603-62
Status Completed
Phase N/A
First received December 19, 2007
Last updated August 7, 2015
Start date April 2006
Est. completion date December 2011

Study information
Verified date August 2015
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority United States: Institution Review Board
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 171
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Calprotectin assay at IU in last 12 months

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Indiana University Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

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