Probiotics Role in HPV Cervico-vaginal Infection Clearance

Study Overview
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Brief Summary
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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
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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).

Official Title
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Probiotics Role in HPV Clearance When Coexisting Vaginal Infections

Conditions
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Vaginal Infection, HPV Infection

Intervention / Treatment
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* Other: Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1 - ARM WITH STANDARD TREATMENT<br>Standard specific treatment for vaginal infections following latest version of CDC guidelines | |
| Experimental: Group 2 - ARM WITH STANDARD TREATMENT PLUS PROBIOTICS IMPLEMENTATION<br>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) | Other: Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1<br>* Probiotics implementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of a possible role of probiotics in HPV clearance | Changes in HPV test positivity | 12 months | 
| Evaluation in vaginal infection resolution | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal infections, probiotics, HPV