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

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.

NCT Number	NCT07089420
Lead Sponsor	American Laboratory Products Company
Conditions	IBD (Inflammatory Bowel Disease), IBS - Irritable Bowel Syndrome, Crohn Disease (CD), UC - Ulcerative Colitis
Enrollment	121 participants
Start Date	2025-07-07
Primary Completion	2026-04-15 (estimated)
Study Completion	2026-04-15 (estimated)
Updated on ClinicalTrials.gov	2026-04-28