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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
chlorhexidine gluconate 4%
Other interventionIn case BV associated bacteria will be identified (using molecular sequencing) in male samples, decolonization attempt will be conducted, using a daily wash for 5 days with chlorhexidine gluconate 4%. Following decolonization attempt, male participants will undergo re- sampling, to assess for microbiome changes. In case there is no change in microbial composition, partners will be instructed to repeat decolonization protocol, and apply a 2 cm diameter volume of 2% clindamycin cream topically to the head of the penis and upper shaft (under the foreskin if uncircumcised) twice daily for seven days following repeated decolonization. Re-sampling will follow.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Penile microbiome composition
Characterization of the penile microbial communities using shotgun analysis, and their similarity to the vaginal microbiota composition of their sexual partner.
Time frame
1 year2
Penile microbiome composition after disinfection
Characterization of the penile microbiome composition using shotgun analysis, after disinfection protocol or antibiotic use.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov