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ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool

NCT03082287 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 424

Last updated 2019-11-05

No results posted yet for this study

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

DEVICE

Fecal Calprotectin Level

Measurement of calprotectin in feces

Sponsors & Collaborators

  • MDC Associates, LLC

    collaborator UNKNOWN

  • American Laboratory Products Company

    lead INDUSTRY

Principal Investigators

  • Fran White · MDC Associates

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2019-10-25
Completion
2019-10-25
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 NCT03082287 on ClinicalTrials.gov