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Probiotics Role in HPV Cervico-vaginal Infection Clearance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05109533
Recruitment Status : Completed
First Posted : November 5, 2021
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
Lavinia Domenici, Azienda Ospedaliero, Universitaria Pisana

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.

Condition or disease Intervention/treatment Phase
Vaginal Infection HPV Infection Other: Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 483 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Probiotics Role in HPV Clearance When Coexisting Vaginal Infections
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Group 1 - ARM WITH STANDARD TREATMENT
Standard specific treatment for vaginal infections following latest version of CDC guidelines
Experimental: 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)
Other: Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1
Probiotics implementation




Primary Outcome Measures :
  1. Evaluation of a possible role of probiotics in HPV clearance [ Time Frame: 12 months ]
    Changes in HPV test positivity

  2. Evaluation in vaginal infection resolution [ Time Frame: 12 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Vaginal infection as inclusion criteria
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05109533


Locations
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Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy, 56120
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
Publications:
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Responsible Party: Lavinia Domenici, Principal Investigator, Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier: NCT05109533    
Other Study ID Numbers: 3644
First Posted: November 5, 2021    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lavinia Domenici, Azienda Ospedaliero, Universitaria Pisana:
vaginal infections
probiotics
HPV
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Papillomavirus Infections
Disease Attributes
Pathologic Processes
DNA Virus Infections
Virus Diseases
Tumor Virus Infections