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

Not Applicable

Recruiting

• Conditions: Bacterial Vaginosis; Microbial Colonization

• Registration Number: NCT05963711
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-17
• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-07-26
• Study First Posted: 2023-07-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-15
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Penile microbiome composition	1 year	Characterization of the penile microbial communities using shotgun analysis, and their similarity to the vaginal microbiota composition of their sexual partner.
Penile microbiome composition after disinfection	1 year	Characterization of the penile microbiome composition using shotgun analysis, after disinfection protocol or antibiotic use.

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel