About this trial
Observational, single-center, non-pharmacological, prospective study of adult patients affected by Inflammatory Bowel Disease (IBD) with an ongoing disease exacerbation requiring hospitalization
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥18 years with Inflammatory Bowel Disease (IBD) with worsening of IBD-related symptoms requiring hospital admission
Signing of informed consent
Performed endoscopic biopsies to confirm/exclude CMV organ disease
Disqualifiers
None
Trial population
Adult patients with inflammatory bowel disease (IBD), either outpatients or requiring hospital admission, who undergo colonic biopsy for recurrence of the underlying disease, will be screened for inclusion
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Diagnostic Performance of CMV-DNA Quantification in Blood and Fecal Samples Compared to Immunohistochemistry on Biopsy for CMV Infection Diagnosis
Evaluation of the diagnostic performance of different methods used for the diagnosis of CMV infection, i.e. CMV-DNA on blood and CMV-DNA on fecal samples - comparing them with the gold standard, i.e. immunohistochemical investigation on biopsy sample in patients affected by IBD with clinical worsening requiring hospitalization
Secondary outcomes
Concordance Between Positive/Borderline Immunohistochemistry and PCR for CMV on Biopsy Samples
Verify the concordance between positive/borderline immunohistochemistry (microscopic examination using specific antibodies to detect the presence of CMV) on biopsy sample and PCR (Polymerase Chain Reaction) for CMV on the sample itself
Severity of Immunohistochemical Pattern and Its Relationship with Clinical Evolution
Verify if there is a relationship between the severity of the immunohistochemical pattern and clinical evolution and/or the need for major abdominal surgery (colectomy, stoma placement, etc.). Measurement Tools: Immunohistochemistry (Analysis of the severity of the immunohistochemical pattern in biopsy samples, focusing on CMV-related markers); Clinical Assessment (Evaluation of clinical evolution, including the need for major abdominal surgeries)
Viral Load in Biopsy Samples and Its Correlation with Clinical Outcomes
Verify whether there is a relationship between viral load on biopsy sample and clinical evolution and/or need for major abdominal surgery (colectomy, stoma placement, etc.) Correlation between viral load in biopsy samples and clinical outcomes and/or implications for major abdominal surgery (colectomy, stoma placement, etc.)
Impact of Antiviral Treatment on Clinical Evolution
Evaluate the impact of an antiviral treatment on clinical evolution and/or need for major abdominal surgery (colectomy, stoma placement, etc.)
Sponsors and contacts
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