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Probiotics Role in HPV Cervico-vaginal Infection Clearance

Primary Purpose

Vaginal Infection, HPV Infection

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1
Sponsored by
Azienda Ospedaliero, Universitaria Pisana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vaginal Infection focused on measuring vaginal infections, probiotics, HPV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Azienda Ospedaliera Universitaria Pisana

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group 1 - ARM WITH STANDARD TREATMENT

Group 2 - ARM WITH STANDARD TREATMENT PLUS PROBIOTICS IMPLEMENTATION

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Evaluation of a possible role of probiotics in HPV clearance
Changes in HPV test positivity
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

Secondary Outcome Measures

Full Information

First Posted
August 17, 2021
Last Updated
November 4, 2021
Sponsor
Azienda Ospedaliero, Universitaria Pisana
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1. Study Identification

Unique Protocol Identification Number
NCT05109533
Brief Title
Probiotics Role in HPV Cervico-vaginal Infection Clearance
Official Title
Probiotics Role in HPV Clearance When Coexisting Vaginal Infections
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero, Universitaria Pisana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Infection, HPV Infection
Keywords
vaginal infections, probiotics, HPV

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
483 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - ARM WITH STANDARD TREATMENT
Arm Type
No Intervention
Arm Description
Standard specific treatment for vaginal infections following latest version of CDC guidelines
Arm Title
Group 2 - ARM WITH STANDARD TREATMENT PLUS PROBIOTICS IMPLEMENTATION
Arm Type
Experimental
Arm 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)
Intervention Type
Other
Intervention Name(s)
Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1
Intervention Description
Probiotics implementation
Primary Outcome Measure Information:
Title
Evaluation of a possible role of probiotics in HPV clearance
Description
Changes in HPV test positivity
Time Frame
12 months
Title
Evaluation in vaginal infection resolution
Description
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
Time Frame
12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Vaginal infection as inclusion criteria
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Azienda Ospedaliera Universitaria Pisana
City
Pisa
ZIP/Postal Code
56120
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34155727
Citation
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.
Results Reference
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PubMed Identifier
29304768
Citation
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.
Results Reference
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PubMed Identifier
26142892
Citation
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.
Results Reference
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Probiotics Role in HPV Cervico-vaginal Infection Clearance

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