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RECRUITING
NCT06810518

ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool

Sponsor: American Laboratory Products Company

View on ClinicalTrials.gov

Summary

The ALPCO Calprotectin CLIA 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. The goal of the study is to generate data to support positive and negative predictive value of the ALPCO Calprotectin assay in patients with signs and symptoms of IBS or IBD.

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

OBSERVATIONAL

Enrollment

220

Start Date

2025-03-25

Completion Date

2026-12-31

Last Updated

2026-02-11

Healthy Volunteers

Yes

Interventions

DEVICE

ALPCO Calprotectin CLIA

Measurement of calprotectin in feces

Locations (3)

Med-Care Research Corp

Miami, Florida, United States

ALPCO

Salem, New Hampshire, United States

Gastro Intestinal Research Institute of Northern Ohio,

Westlake, Ohio, United States