Understanding HPV Infection in Men with Inflammatory Bowel Disease
Prevalence and Clinical Implications of Human Papillomavirus Infection in the Male Population With Inflammatory Bowel Disease
This study looks at how common HPV infections are in men with Inflammatory Bowel Disease by testing samples from their mouths and bottoms to see if there are any related health risks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 384 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | Male |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05911750 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the prevalence of Human Papillomavirus (HPV) infection in anal and oral samples from male patients diagnosed with Inflammatory Bowel Disease (IBD). Participants will undergo anal and oral swabs for HPV DNA testing and cytologic analysis, while also completing a questionnaire about their IBD characteristics and treatment. The study aims to identify risk factors associated with HPV infection and to assess the presence of HPV-related lesions in these patients. Findings may help inform future screening and treatment strategies for this population.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 to 79 with a diagnosis of Crohn's disease or ulcerative colitis for at least three months.
Not a fit: Patients with unclassified inflammatory bowel disease or those unable to provide biological samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and management strategies for HPV infection in male IBD patients.
How similar studies have performed: While studies on HPV prevalence in IBD patients are limited, similar research in other populations has shown significant findings regarding HPV infection rates.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed Crohn's disease or ulcerative colitis (at least 3 months before enrollment) * Male * Age from 18 to 79 years Exclusion Criteria: * Unclassified Inflammatory Bowel Disease * Diarrhea (\> 3 bowel movements/day) with rectal bleeding at enrollment * Prior full proctectomy * Inability to collect the biological samples * Inability to complete the questionnaire * Refusal to sign the informed consent
Where this trial is running
Barcelona
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Antonio Giordano, MD — dr.antoniogiordano@gmail.com
- Study coordinator: Antonio Giordano, MD
- Email: dr.antoniogiordano@gmail.com
- Phone: 0034 932919000
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.