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

NCT06810518 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
  • Inflammatory Bowel Syndrome

Interventions

DEVICE

ALPCO Calprotectin CLIA

Measurement of calprotectin in feces

Sponsors & Collaborators

  • American Laboratory Products Company

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06810518 on ClinicalTrials.gov