Probiotics Role in HPV Cervico-vaginal Infection Clearance

HPV Infection Clinical Trial

Official title:

Probiotics Role in HPV Clearance When Coexisting Vaginal Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05109533
• Other study ID #: 3644
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: November 2021
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HPV Infection
• Infections
• Papillomavirus Infections
• Vaginal Infection

Intervention

Other:
• Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1
Probiotics implementation

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of a possible role of probiotics in HPV clearance	Changes in HPV test positivity	12 months
Primary	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