NCT02351635

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

Clinical Study of the BÜHLMANN fCAL™ ELISA as an Aid in the Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 478 (actual)
• Sponsor: Bühlmann Laboratories AG · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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

• Inflammatory Bowel Disease
• Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	fecal calprotectin level	Stool sample collected by the subject, sent study laboratories where fecal calprotectin levels are quantified.

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-03-01
• Completion: 2018-04-01
• First posted: 2015-01-30
• Last updated: 2019-01-18

Locations

7 sites across 1 country: United States