Vaginal InfectionNCT05109533
Probiotics Role in HPV Cervico-vaginal Infection Clearance
A study testing Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1 in people with Vaginal Infection and HPV Infection, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Infection, HPV Infection
- What is being tested?
- Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 483 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age > 18 years
- positive swabs for vaginal infections detected during colposcopy check
- HPV test positivity
Who cannot join
- pregnancy or breastfeeding
- concomitant malignancies
- immunological diseases
- severe comorbidities
- prolonged corticosteroid treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics Role in HPV Clearance When Coexisting Vaginal Infections
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.
Read the 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).
- Conditions
- Vaginal Infection, HPV Infection
- Being tested
- Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1
- Keywords
- vaginal infections, probiotics, HPV
- Medical subject headings
- Vaginitis, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1Other
Probiotics implementation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - ARM WITH STANDARD TREATMENT | No intervention | Standard specific treatment for vaginal infections following latest version of CDC guidelines |
| Group 2 - ARM WITH STANDARD TREATMENT PLUS PROBIOTICS IMPLEMENTATION | Experimental | 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) Receives: Other: Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of a possible role of probiotics in HPV clearance
Changes in HPV test positivity
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vaginal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lavinia Domenici, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109533
- Sponsor's protocol ID
- 3644
- Status last verified
- Nov 2021
- First submitted
- 17 Aug 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34155727Palma 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.
PubMed 29304768Recine 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.
PubMed 26142892
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics Role in HPV Clearance When Coexisting Vaginal Infections
- ClinicalTrials.gov ID
- NCT05109533
- Acronym / sponsor ID
- 3644
- Conditions
- Vaginal Infection, HPV Infection
- Keywords
- vaginal infections, probiotics, HPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - ARM WITH STANDARD TREATMENT | No intervention | –Standard specific treatment for vaginal infections following latest version of CDC guidelines |
| Group 2 - ARM WITH STANDARD TREATMENT PLUS PROBIOTICS IMPLEMENTATION | Experimental | Other: Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1Standard 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years
- positive swabs for vaginal infections detected during colposcopy check
- HPV test positivity
Key exclusion criteria (5 listed)
- pregnancy or breastfeeding
- concomitant malignancies
- immunological diseases
- severe comorbidities
- prolonged corticosteroid treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1Probiotics implementation | Other | Group 2 - ARM WITH STANDARD TREATMENT PLUS PROBIOTICS IMPLEMENTATION |
Primary outcome
Evaluation of a possible role of probiotics in HPV clearance
Time frame: 12 months
Changes in HPV test positivity
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Background: PubMed 34155727Domenici 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.
- Background: PubMed 29304768Palma 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.
- Background: PubMed 26142892Recine 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1 in people with Vaginal Infection and HPV Infection, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of a possible role of probiotics in HPV clearance (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05109533, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.