NCT05109533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
483

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
Last Updated

November 5, 2021

Status Verified

November 1, 2021

Enrollment Period

3 years

First QC Date

August 17, 2021

Last Update Submit

November 4, 2021

Conditions

Vaginal InfectionHPV Infection

Keywords

vaginal infectionsprobioticsHPV

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Group 1 - ARM WITH STANDARD TREATMENT

NO INTERVENTION

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

Group 2 - ARM WITH STANDARD TREATMENT PLUS PROBIOTICS IMPLEMENTATION

EXPERIMENTAL

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

Interventions

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

Probiotics implementation

Group 2 - ARM WITH STANDARD TREATMENT PLUS PROBIOTICS IMPLEMENTATION

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsVaginal infection as inclusion criteria
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • positive swabs for vaginal infections detected during colposcopy check
  • HPV test positivity

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Universitaria Pisana

Pisa, 56120, Italy

Location

Related Publications (3)

  • 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.

    PMID: 34155727BACKGROUND

  • 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.

    PMID: 29304768BACKGROUND

  • 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.

    PMID: 26142892BACKGROUND

MeSH Terms

Conditions

VaginitisPapillomavirus Infections

Condition Hierarchy (Ancestors)

Vaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2021

First Posted

November 5, 2021

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

November 5, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)