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BÜHLMANN fCAL™ ELISA - Aid in Differentiation of IBD From IBS

NCT02351635 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 478

Last updated 2019-01-18

No results posted yet for this study

Summary

The purpose of this study is to confirm the sensitivity and specificity of the BÜHLMANN fCAL™ ELISA as an aid in diagnosis to differentiate between Inflammatory Bowel Disease (IBD; Crohn's Disease (CD), Ulcerative Colitis (UC), or indeterminate colitis) and Irritable Bowel Syndrome (IBS).

To estimate the predictive value of a positive test (positive predictive value (PPV)) and the predictive value of a negative test (Negative Predictive Value (NPV)) using the proposed test outcomes for BÜHLMANN Calprotectin Test results when used in patients referred for diagnostic evaluation with signs and symptoms suggestive of either IBS or IBD.

To confirm the inter-laboratory consistency of test results for the BÜHLMANN fCAL™ ELISA.

To provide exploratory observations of test results in patients between the age of 2 and 21 years.

To provide a sample set from normal subjects with no symptoms or signs of gastrointestinal disease for use in Expected Value Testing.

Conditions

Interventions

OTHER

fecal calprotectin level

Stool sample collected by the subject, sent study laboratories where fecal calprotectin levels are quantified.

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • Bühlmann Laboratories AG

    lead INDUSTRY

Principal Investigators

  • Allison Gorman · ICON Clincal Research

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-03-31
Completion
2018-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02351635 on ClinicalTrials.gov