HPV Infection Clinical Trial
Official title:
Probiotics Role in HPV Clearance When Coexisting Vaginal Infections
NCT number | NCT05109533 |
Other study ID # | 3644 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | March 31, 2021 |
Verified date | November 2021 |
Source | Azienda Ospedaliero, Universitaria Pisana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Universitaria Pisana | Pisa |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero, Universitaria Pisana |
Italy,
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
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 |
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