Prevalence and Clinical Implications of HPV Infection in Male IBD Patients
Observational · No treatment assigned · 1 site · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: HPV Infection, Dysplasia Anus and Oral Cavity Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 79
- Men only
Some of the main requirements, copied from the record:
- Diagnosed Crohn's disease or ulcerative colitis (at least 3 months before enrollment)
- Male
- Age from 18 to 79 years
There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 384 participants are expected to take part.
- Start date: 2023-02-12.
- Main results expected around 2026-01-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Spain.
Main thing being measured
- Prevalence (number/percentage) of HPV infection in oral and anal samples (Up to 12 months)
In the researchers’ words
The study aims at describing the prevalence of Human Papillomavirus (HPV) infection in anal and oral samples of men with Inflammatory Bowel Disease (IBD) and detecting risk factors for the infection.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | HPV Infection; Dysplasia Anus; Oral Cavity Disease |
| Lead sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Enrollment | 384 (estimated) |
| Start date | 2023-02-12 |
| Primary completion (est.) | 2026-01-31 |
| First posted | 2023-06-22 |
| Last updated | 2025-09-12 |
| Official title | Prevalence and Clinical Implications of Human Papillomavirus Infection in the Male Population With Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT05911750 |
Interventions
- Anal pap smear and oral swab for cytology and HPV testing (Diagnostic Test)
Anal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.