The Genital Microbiome of Male Partners of Women with Recurrent BV Undergoing Vaginal Microbiome Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorHadassah Medical Organization
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Treatments tested in this trial
- chlorhexidine gluconate 4%
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov