Salem

Researchers are evaluating the ALPCO Calprotectin CLIA, an in vitro diagnostic test designed to measure calprotectin levels in human stool samples. Calprotectin is a protein marker of inflammation in the gut, and measuring it can help in diagnosing Inflammatory Bowel Diseases (IBD) such as Crohn's Disease and Ulcerative Colitis. The study aims to confirm how well this test distinguishes between IBD and Irritable Bowel Syndrome (IBS) by assessing its sensitivity and specificity using cut-off values of 50 and 100 g/g. Participants with symptoms suggesting IBS or IBD will provide stool samples either within 72 to 24 hours before a scheduled colonoscopy or 3 to 30 days after, provided treatment has not started. Multiple clinical sites will conduct the study, with at least three analytical sites, including ALPCO, testing all collected samples. The results of the calprotectin test will be compared to the diagnosis determined by colonoscopy and histology to evaluate the test's predictive value. During the study, patients will undergo colonoscopy procedures and provide stool samples stored frozen until testing. Researchers will analyze the agreement between the calprotectin levels and the clinical diagnosis. The main outcome measure is the diagnostic value of calprotectin over the study duration, up to 52 weeks. The study expects to enroll around 220 patients with suspected IBD or IBS and about 100 normal patients without a history of disease for comparison.