Actively Recruiting
The Genital Microbiome of Male Partners of Women with Recurrent BV Undergoing Vaginal Microbiome Transplantation
Led by Hadassah Medical Organization · Updated on 2025-03-19
100
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
The Genital Microbiome of Male Partners of Women with Recurrent BV Undergoing Vaginal Microbiome Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The subject has a female partner who participates in vaginal microbiota transplantation (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 will not qualify if you...
- A known skin disease involving the penile skin.
- A known sensitivity to chlorhexidine gluconate.
- Either partner (female or male) has more than one sexual partner.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hadassah Medical Center
Jerusalem, Israel
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
0
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