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

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.

NCT Number	NCT05963711
Lead Sponsor	Hadassah Medical Organization
Conditions	Bacterial Vaginosis, Microbial Colonization
Enrollment	100 participants
Start Date	2022-10-17
Primary Completion	2025-12 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2025-03-19