Probiotics Role in HPV Clearance When Coexisting Vaginal Infections
| Registry | NCT05109533 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 483 (Actual) |
| Sponsor | Azienda Ospedaliero, Universitaria Pisana (Other) |
| Conditions | Vaginal Infection, HPV Infection |
| Interventions | Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1 (Other) |
| Dates | start 2018-01-01, primary completion 2020-12-31, completion 2021-03-31, first posted 2021-11-05, last updated 2021-11-05 |
| Locations | 1 site in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Vaginal Infection All trials for HPV Infection All trials of Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1
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.
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group 1 - ARM WITH STANDARD TREATMENT | No intervention | Standard specific treatment for vaginal infections following latest version of CDC guidelines | |
| Group 2 - ARM WITH STANDARD TREATMENT PLUS PROBIOTICS IMPLEMENTATION | Experimental | Other: Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1 | Standard specific treatment for vaginal infections plus long-lasting (9 months) vaginal and oral probiotics implementation (Lactobacillus rhamnosus BMX 54 vaginally and Lactobacillus reuteri RC-14/Lactobaciullus rhamnosus GR-1 combination orally) |
Sex: Female, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Azienda Ospedaliera Universitaria Pisana | Pisa | Italy |