Clinical trial NCT05109533: Probiotics Role in HPV Cervico-vaginal Infection Clearance
Official title: Probiotics Role in HPV Clearance When Coexisting Vaginal Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Infection
HPV Infection
Keywords: vaginal infections
probiotics
HPV
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 483
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Evaluation of a possible role of probiotics in HPV clearance
timeFrame: 12 months
measure: Evaluation in vaginal infection resolution
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
Study officials:
References:
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.
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.
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.