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Probiotics Role in HPV Cervico-vaginal Infection Clearance

NCT ID: NCT05109533

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

483 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-03-31

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).

Conditions

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Vaginal Infection HPV Infection

Keywords

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vaginal infections probiotics HPV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group 1 - ARM WITH STANDARD TREATMENT

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2 - ARM WITH STANDARD TREATMENT PLUS PROBIOTICS IMPLEMENTATION

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)

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Probiotics implementation

Interventions

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

Probiotics implementation

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role lead

Responsible Party

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Lavinia Domenici

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliera Universitaria Pisana

Pisa, , Italy

Site Status

Countries

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Italy

References

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Domenici L. Letter to "The application of PAX1 methylation detection and HPV E6/E7 mRNA detection in cervical cancer screening". J Obstet Gynaecol Res. 2021 Sep;47(9):3419-3420. doi: 10.1111/jog.14912. Epub 2021 Jun 21. No abstract available.

Reference Type BACKGROUND
PMID: 34155727 (View on PubMed)

Palma E, Recine N, Domenici L, Giorgini M, Pierangeli A, Panici PB. Long-term Lactobacillus rhamnosus BMX 54 application to restore a balanced vaginal ecosystem: a promising solution against HPV-infection. BMC Infect Dis. 2018 Jan 5;18(1):13. doi: 10.1186/s12879-017-2938-z.

Reference Type BACKGROUND
PMID: 29304768 (View on PubMed)

Recine N, Palma E, Domenici L, Giorgini M, Imperiale L, Sassu C, Musella A, Marchetti C, Muzii L, Benedetti Panici P. Restoring vaginal microbiota: biological control of bacterial vaginosis. A prospective case-control study using Lactobacillus rhamnosus BMX 54 as adjuvant treatment against bacterial vaginosis. Arch Gynecol Obstet. 2016 Jan;293(1):101-107. doi: 10.1007/s00404-015-3810-2. Epub 2015 Jul 5.

Reference Type BACKGROUND
PMID: 26142892 (View on PubMed)

Other Identifiers

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3644

Identifier Type: -

Identifier Source: org_study_id