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

Hadassah Medical Center

Status: Enrolling

Conditions: Microbial Colonization; Bacterial Vaginosis

Treatments: Other: chlorhexidine gluconate 4%

Study type: Interventional

Funder types: Other

Identifiers

NCT05963711

0463-22-HMO

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)