Examining the genital microbiome of male partners of women with recurrent bacterial vaginosis
Official title: The Penile Microbiome in Partners of Women With Recurrent BV and Its Response to Decolonization Protocol
Run by Hadassah Medical Organization · NCT05963711 · Data updated 2026-11-12
This study is testing if the bacteria in the genital area of men can affect how often their female partners get bacterial vaginosis and whether cleaning with a certain solution can help reduce this risk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 100 (estimated) |
| Sponsor | Hadassah Medical Organization Academic / other |
| Locations | 1 site (Jerusalem) |
| Status | Recruiting |
| Started | October 17, 2022 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | September 23, 2026 |
| Trial ID | NCT05963711 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include male partners of women participating in the vaginal microbiome transplantation study who are willing to comply with the study protocols.
✕Probably not a fit
Patients who have skin diseases affecting the penile area or known sensitivities to chlorhexidine gluconate may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the role of the male partner's genital microbiome in the recurrence of bacterial vaginosis (BV) in women undergoing vaginal microbiome transplantation. It aims to determine if the penile microbiome contributes to BV recurrence and whether disinfection using chlorhexidine gluconate can eliminate BV-associated bacteria. The study involves male partners of women who are participating in a related vaginal microbiome transplantation study and requires adherence to a condom use protocol. The findings could provide insights into the sexual transmission dynamics of BV.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing recurrent bacterial vaginosis in women by addressing the role of male partners.
How similar studies have gone: While previous studies have not shown benefit from treating male partners for BV, this approach of examining the male microbiome in conjunction with vaginal microbiome transplantation is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
-
Hadassah Medical Center
Jerusalem, Israel Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.