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

NCT07089420 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

  • IBD (Inflammatory Bowel Disease)
  • IBS - Irritable Bowel Syndrome
  • Crohn Disease (CD)
  • UC - Ulcerative Colitis

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
2025-07-07
Primary Completion
2026-04-15
Completion
2026-04-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT07089420 on ClinicalTrials.gov