Comparing tests for diagnosing cytomegalovirus in patients with inflammatory bowel disease
Comparison of Diagnostic Tests for the Diagnosis of CYTOmegalovirus Organ Disease in Patients With Intestinal BOweL Diseases
This study is testing different ways to diagnose cytomegalovirus in adults with inflammatory bowel disease who are having worse symptoms and need to be hospitalized.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06793124 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on adult patients with inflammatory bowel disease (IBD) who are experiencing a worsening of their symptoms and require hospitalization. It aims to evaluate the effectiveness of various diagnostic tests for identifying cytomegalovirus (CMV) organ disease, which can be challenging due to overlapping symptoms and the complexity of the immune response in these patients. The study will involve endoscopic biopsies and assessments of viral load through different methods, including PCR, to determine the most reliable diagnostic approach for CMV in the context of IBD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with inflammatory bowel disease experiencing a worsening of symptoms that necessitates hospitalization.
Not a fit: Patients who do not have inflammatory bowel disease or are not experiencing exacerbations of their symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing CMV organ disease in IBD patients, leading to better-targeted treatments.
How similar studies have performed: While there have been studies exploring diagnostic methods for CMV in IBD, this specific approach of comparing various diagnostic tests is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: /
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Matteo Rinaldi, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Matteo Rinaldi, MD
- Email: matteo.rinaldi23@unibo.it
- Phone: +390512144302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.