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

Recruiting now · Not applicable

Conditions studied: Bacterial Vaginosis, Microbial Colonization

In brief

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.

Key facts

Study ID

NCT05963711

Run by

Hadassah Medical Organization

People needed

100

Starts

2022-10-17

Expected to finish

2026-06-01

Last updated by the study team

2025-03-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Hadassah Medical Center — Jerusalem, Israel (enrolling)

Full record on ClinicalTrials.gov

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