NCT03082287

ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 424 (actual)
• Sponsor: American Laboratory Products Company · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

The ALPCO Calprotectin ELISA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. This study will estimate the predictive values of a negative (NPV) and positive (PPV) test by utilizing the assay outcomes of the ALPCO Calprotectin ELISA.

Conditions

• Inflammatory Bowel Diseases
• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DEVICE	Fecal Calprotectin Level	Measurement of calprotectin in feces

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-10-25
• Completion: 2019-10-25
• First posted: 2017-03-17
• Last updated: 2019-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study