The Genital Microbiome of Male Partners of Women with Recurrent BV Undergoing Vaginal Microbiome Transplantation

Launched by HADASSAH MEDICAL ORGANIZATION · Jul 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the role of male partners' genital bacteria in the recurring condition known as Bacterial Vaginosis (BV) in women. Researchers believe that BV can be passed between sexual partners, and they want to explore whether the bacteria found in men may contribute to BV returning in women who are undergoing a specific treatment called vaginal microbiota transplantation. The study will also look into whether cleaning the penis can help eliminate these BV-related bacteria.

To be eligible for this trial, men must be in a committed relationship with a woman who is participating in the vaginal microbiota transplantation study. They should agree to use condoms as instructed and follow a cleaning protocol for their genital area. However, men with certain skin conditions on the penis or allergies to specific cleaning products cannot participate. This study is currently recruiting men aged 65 to 74, and participants will have the opportunity to contribute to important research that could improve treatment for BV in women.

Gender

MALE

Eligibility 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.