NCT05109533

Probiotics Role in HPV Cervico-vaginal Infection Clearance

Probiotics Role in HPV Clearance When Coexisting Vaginal Infections

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 483 (actual)
• Sponsor: Azienda Ospedaliero, Universitaria Pisana · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Vaginal Infection
• HPV Infection

Interventions

Type	Name	Description
OTHER	Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1	Probiotics implementation

Timeline

• Start date: 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 across 1 country: Italy