HPV Infection, Vaginal Infection
Conditions
Keywords
vaginal infections, probiotics, HPV
Brief summary
Vaginal infections demonstrated to be implicated in the persistence of HPV, activating a vicious circle of vaginal microbial perturbations. HPV infection can destroy the biofilm barrier formed by the local vaginal immune microenvironment, leading to a condition called dysbiosis. Contemporarily, the resulting local microecological imbalance in the vagina can subsequently upregulate the expression of the HPV protein, increasing HPV-related cytological alterations.
Detailed description
A total of 483 women affected by different vaginal infections and concomitant HPV-positivity were enrolled between 2018 and 2020 at Department of Gynecological, Obstetrical and Urological Sciences, University Sapienza of Rome (Rome, Italy) and 2nd Division of Obstetrics and Gynecology, Azienda Ospedaliera Universitaria Pisana, University of Pisa (Pisa, Italy). Women with positive swabs for infections were randomized in two groups, standard specific treatment (n=231) versus the standard treatment plus long-lasting (9 months) vaginal and oral probiotics implementation (n=252).
Interventions
OTHERLactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1
Probiotics implementation
Sponsors
Azienda Ospedaliero, Universitaria Pisana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age \> 18 years * positive swabs for vaginal infections detected during colposcopy check * HPV test positivity
Exclusion criteria
* pregnancy or breastfeeding * concomitant malignancies * immunological diseases * severe comorbidities * prolonged corticosteroid treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of a possible role of probiotics in HPV clearance | 12 months | Changes in HPV test positivity |
| Evaluation in vaginal infection resolution | 12 months | Negative swab test for vaginal infections, complete symptoms resolution, absence of colposcopy findings suggestive for permanence of infections (e.g. colpitis, fine punctuation, etc), absence of infection following Amsel's criteria |
Countries
Italy
Outcome results
None listed