Examining the genital microbiome of male partners of women with recurrent bacterial vaginosis
The Penile Microbiome in Partners of Women with Recurrent BV and Its Response to Decolonization Protocol
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Hadassah Medical Organization Academic / other |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT05963711 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have skin diseases affecting the penile area or known sensitivities to chlorhexidine gluconate may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Jerusalem
- Hadassah Medical Center — Jerusalem, Israel (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.