Study of ALPCO Calprotectin CLIA Device Measuring Calprotectin in Stool to Help Diagnose Inflammatory Bowel Disease and Differentiate It from Irritable Bowel Syndrome in Adults

What this Trial Is About

Researchers are evaluating the ALPCO Calprotectin CLIA, an in vitro diagnostic test designed to measure the concentration of calprotectin in stool samples. Calprotectin is a protein marker of inflammation in the gut, and measuring it can help distinguish between Inflammatory Bowel Diseases IBD like Crohns Disease and Ulcerative Colitis, and Irritable Bowel Syndrome IBS. This observational study aims to confirm the tests sensitivity and specificity compared to gastroenterologist diagnosis, including colonoscopy and clinical information, to support its predictive value for IBD and IBS. Participants will provide stool samples before or shortly after a scheduled colonoscopy, and these samples will be tested using the ALPCO Calprotectin CLIA device. The study will enroll patients with suspected IBD or IBS symptoms and include groups diagnosed with IBD, IBS, other gastrointestinal disorders, and healthy subjects without gastrointestinal complaints. The test results will be compared to colonoscopy and histology findings to determine the diagnostic accuracy using proposed cut-off values for calprotectin levels. During the study, patients will undergo diagnostic evaluation including colonoscopy and provide stool samples according to protocol. Samples will be stored frozen until testing. Researchers will measure the calprotectin levels and compare these results to clinical diagnoses to assess the tests predictive ability. The primary outcome measure is the in vitro diagnostic value of calprotectin across up to 52 weeks. The study includes multiple clinical sites and plans to enroll around 220 patients, with additional healthy controls, ensuring comprehensive evaluation of the tests diagnostic performance.

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