HPV-related Cytological Abnormalities on PAP Smear (LSIL) Clinical Trial
| NCT number | NCT01097356 |
| Other study ID # | 2414VV |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 2010 |
| Est. completion date | December 2011 |
| Verified date | September 2021 |
| Source | Universiteit Antwerpen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Aim: In this project proposition the investigators would like to examine the effect of immune modulation by probiotics on the clearance of HPV-infections. This study provides a model for viral infection but also for cancer precursors. This would be an excellent model (and the only possible short-term model) to examine an effect on cancer precursors. Cancer precursors (cytological abnormalities such as L-SIL) are a scientifically accepted surrogate endpoint for cervical cancer, for example in HPV-vaccine studies. Research question: Does daily intake of probiotics lead to a better immune-response in HPV-infected women, i.e. does it facilitate clearance of the virus and/or regression of cytological lesions?
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | December 2011 |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - women with a new LSIL diagnosis an HPV positivity on PAP smear Exclusion Criteria: - women over 65 - immunocompromised patients (because of disease or drugs) |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Veronique Verhoeven | Wilrijk |
| Lead Sponsor | Collaborator |
|---|---|
| Universiteit Antwerpen |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 1.proportion of HPV positives in both arms | 6months | ||
| Primary | 2. proportion of regression of LSIL lesion in both arms | 6 months |