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RECRUITING
NCT07089420

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

Sponsor: American Laboratory Products Company

View on ClinicalTrials.gov

Summary

This study is evaluating the levels of calprotectin, a protein found in stool, in healthy adults. Calprotectin is a marker of inflammation in the intestines and can help doctors tell the difference between inflammatory bowel diseases (IBD), like Crohn's disease or ulcerative colitis, and non-inflammatory conditions like irritable bowel syndrome (IBS). In this study, healthy volunteers aged 22 and older will collect a stool sample at home using a simple kit and mail it to the study site. The samples will be tested using a new laboratory method called the ALPCO Calprotectin CLIA assay. The goal is to confirm what level of calprotectin is considered "normal" in people without intestinal disease. Participation involves just one stool sample, and there are no medical procedures. Volunteers will be compensated for their time. The study will help improve how doctors interpret calprotectin test results in clinical settings.

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2025-07-07

Completion Date

2026-10

Last Updated

2026-02-11

Healthy Volunteers

Yes

Interventions

DEVICE

ALPCO Calprotectin CLIA

Measurement of calprotectin in feces

Locations (1)

ALPCO

Salem, New Hampshire, United States