HPV-related Cytological Abnormalities on PAP Smear (LSIL)
Conditions
Brief summary
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?
Interventions
DIETARY_SUPPLEMENTprobiotic drinkers
HPV+, LSIL patients in this arm will drink the probiotic study drink for a period of 6 months
Sponsors
Universiteit Antwerpen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.proportion of HPV positives in both arms | 6months |
| 2. proportion of regression of LSIL lesion in both arms | 6 months |
Countries
Belgium
Outcome results
None listed