Bacterial VaginosisNCT05963711
The Genital Microbiome of Male Partners of Women With Recurrent BV Undergoing Vaginal Microbiome Transplantation
A study testing chlorhexidine gluconate 4% in people with Bacterial Vaginosis and Microbial Colonization, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
There is strong observational evidence that sexual activity plays a key role in Bacterial Vaginosis (BV) acquisition and recurrence. Microbiological data support the contribution of sexual transmission to the pathogenesis of BV through the exchange of BV-associated bacteria (BVAB) between sexual partners. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis, Microbial Colonization
- What is being tested?
- chlorhexidine gluconate 4%
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 17 Oct 2022to Dec 2026
- Phase
- Interventional
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject has s female partner who participates in VMT study ( NCT04517487).
- The subject is defined by the woman as her male regular partner.
- Willing to use a condom as instructed by the protocol.
- Willing to comply with decolonization protocol.
Who cannot join
- A known skin disease involving the penile skin.
- A known sensitivity to chlorhexidine gluconate
- Any of the partners (female/male) has more than one sexual partner.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem
Ahinoam Lev Sagie, MD, +972-54-4327178, levsagie@netvision.net.il
About this study
Official title: The Penile Microbiome in Partners of Women With Recurrent BV and Its Response to Decolonization Protocol
There is strong observational evidence that sexual activity plays a key role in Bacterial Vaginosis (BV) acquisition and recurrence. Microbiological data support the contribution of sexual transmission to the pathogenesis of BV through the exchange of BV-associated bacteria (BVAB) between sexual partners.
Although BV epidemiology strongly suggests sexual transmission, treatment of sexual partners is not recommended, based on prior treatment studies of male partners of women with recurrent BV, which showed no benefit with male treatment. Nevertheless, male condom use is highly protective against recurrent BV.
This study aims to evaluate the male-partner's genital microbiome as a potential source of BV-recurrence in women undergoing vaginal microbiota transplantation (NCT04517487), and whether disinfection can eliminate BV-associated penile microbiome.
- Conditions
- Bacterial Vaginosis, Microbial Colonization
- Being tested
- chlorhexidine gluconate 4%
- Keywords
- Penile microbiome, Vaginal microbiome transplant, Male partners, Bacterial vaginosis
- Medical subject headings
- Vaginosis, Bacterial, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidine gluconate 4%Other
Also called 2% clindamycin cream
In case BV associated bacteria will be identified (using molecular sequencing) in male samples, decolonization attempt will be conducted, using a daily wash for 5 days with chlorhexidine gluconate 4%. Following decolonization attempt, male participants will undergo re- sampling, to assess for microbiome changes.
In case there is no change in microbial composition, partners will be instructed to repeat decolonization protocol, and apply a 2 cm diameter volume of 2% clindamycin cream topically to the head of the penis and upper shaft (under the foreskin if uncircumcised) twice daily for seven days following repeated decolonization. Re-sampling will follow.
What is being measured
The primary outcome is the main question the study is designed to answer.
Penile microbiome composition
Characterization of the penile microbial communities using shotgun analysis, and their similarity to the vaginal microbiota composition of their sexual partner.
Measured: 1 year
Penile microbiome composition after disinfection
Characterization of the penile microbiome composition using shotgun analysis, after disinfection protocol or antibiotic use.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start17 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- In those with BV-associated penile microbiome, a decolonization attempt will be conducted, (daily wash for 5 days with chlorhexidine gluconate 4%). if decolonization fails, an antibiotic cream will be used to eradicate BV associated bacteria.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahinoam Lev-Sagie, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963711
- Sponsor's protocol ID
- 0463-22-HMO
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No