Actively Recruiting
Comparison of Diagnostic Tests for Cytomegalovirus Organ Disease in Patients With Intestinal Bowel Diseases
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-27
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate different diagnostic tests for detecting cytomegalovirus (CMV) organ disease in adults with inflammatory bowel disease (IBD) who experience worsening symptoms that require hospitalization. Patients with chronic IBD are at higher risk of infections due to immune system problems and treatments that suppress immunity. Diagnosing intestinal CMV disease is challenging because symptoms overlap with IBD flare-ups, and the standard diagnosis relies on biopsy with immunohistochemical analysis, which cannot always distinguish active disease from harmless viral presence. The study compares the performance of blood and fecal CMV-DNA tests against the gold standard biopsy method to identify CMV infection accurately. Biopsies are examined using immunohistochemistry and PCR to measure viral load. The study is observational and non-drug-based, following patients over about two years. It aims to find quicker, reliable diagnostic markers to guide potential antiviral treatment that might reduce the need for surgery. Participants undergo colonic biopsies during hospitalization for IBD flare-ups, with samples tested repeatedly throughout the study. Researchers monitor clinical progress and viral load changes at 30 days and longer-term follow-up. The main outcome is how well blood and stool CMV-DNA tests detect infection compared to biopsy results. This ongoing study includes assessments of treatment impact, biopsy patterns, and patient outcomes to better understand CMV's role in IBD exacerbations.
CONDITIONS
Brief Title
Comparison Diagnostic Tests for the Diagnosis of CYTOmegalovirus Organ Disease in Patients With intestinalBOweL Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 518 years with Inflammatory Bowel Disease (IBD) experiencing worsening symptoms that require hospital admission
- Signing of informed consent
- Undergoing endoscopic biopsies to confirm or exclude CMV organ disease
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants undergo diagnostic tests including colonic biopsy, blood and fecal CMV-DNA measurements to evaluate CMV organ disease in the context of inflammatory bowel disease worsening.
Visits coincide with hospital admissions and biopsies as needed
Duration - Up to 2 years
Participants are monitored for clinical evolution and impact of antiviral treatment over time.
Follow-up visit at 30 days and ongoing evaluations through study completion
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
M
Matteo Rinaldi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here