Probiotics Role in HPV Cervico-vaginal Infection Clearance

Not Applicable

Completed

• Conditions: HPV Infection; Vaginal Infection
• Interventions: Other: Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1

• Registration Number: NCT05109533
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

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).

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31
• Study First Submitted: 2021-08-17
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-04
• Last Update Submitted: 2021-11-04
• Study First Posted: 2021-11-05
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 483

Inclusion Criteria

Not provided

Exclusion Criteria

• pregnancy or breastfeeding
• concomitant malignancies
• immunological diseases
• severe comorbidities
• prolonged corticosteroid treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 - ARM WITH STANDARD TREATMENT PLUS PROBIOTICS IMPLEMENTATION	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)

Primary Outcome Measures

Name	Time	Method
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
Evaluation of a possible role of probiotics in HPV clearance	12 months	Changes in HPV test positivity

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Pisana; 🇮🇹 Pisa, Italy