Probiotics Role in HPV Cervico-vaginal Infection Clearance

Azienda Ospedaliero, Universitaria Pisana

Status: Completed

Conditions: HPV Infection; Vaginal Infection

Treatments: Other: Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1

Study type: Interventional

Funder types: Other

Identifiers

NCT05109533

3644

Details and patient eligibility

About

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.

Full 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).

Enrollment: 483 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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483 participants in 2 patient groups

Group 1 - ARM WITH STANDARD TREATMENT

No Intervention group

Description:

Standard specific treatment for vaginal infections following latest version of CDC guidelines

Group 2 - ARM WITH STANDARD TREATMENT PLUS PROBIOTICS IMPLEMENTATION

Experimental group

Description:

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)

Treatment:

Other: Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1