What this Trial Is About

Researchers are investigating diagnostic methods for detecting cytomegalovirus (CMV) organ disease in adults with inflammatory bowel disease (IBD) who are experiencing a worsening of symptoms that requires hospitalization. This observational, single-center, prospective study focuses on comparing various tests to identify CMV infection, which can be difficult to diagnose due to overlapping symptoms and immune system challenges in IBD patients. The study aims to improve early detection, which may help guide treatment decisions and potentially reduce the need for surgery. The study compares CMV-DNA testing from blood and fecal samples with the current gold standard of diagnosing CMV organ disease: immunohistochemical analysis of biopsy samples taken from the affected intestinal tissue. Participants undergo endoscopic biopsies to confirm or exclude CMV infection. The research evaluates the diagnostic accuracy of these methods over an average two-year period, monitoring viral loads and their relationship to clinical disease. This approach seeks to establish quicker and reliable diagnostic tools that could aid in timely treatment. During the study, patients will have samples collected and tested regularly to assess CMV presence and viral activity. Researchers will perform immunohistochemical tests on biopsy tissue and measure CMV-DNA in blood and fecal samples. The primary outcome is to assess how well these diagnostic methods perform compared to the biopsy gold standard. Patients provide consent and are monitored throughout their hospitalization and follow-up. The study’s findings may contribute to more effective diagnosis and management of CMV in IBD patients.

Comparison Diagnostic Tests for the Diagnosis of CYTOmegalovirus Organ Disease in Patients With intestinalBOweL Diseases