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

Study Overview
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Brief Summary
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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.

Official Title
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The Penile Microbiome in Partners of Women With Recurrent BV and Its Response to Decolonization Protocol

Conditions
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Bacterial Vaginosis, Microbial Colonization

Intervention / Treatment
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* Other: chlorhexidine gluconate 4%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: In those with BV-associated penile microbiome, a decolonization attempt will be conducted, (daily wash for 5 days with chlorhexidine gluconate 4%). if decolonization fails, an antibiotic cream will be used to eradicate BV associated bacteria.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: chlorhexidine gluconate 4%|In 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penile microbiome composition | Characterization of the penile microbial communities using shotgun analysis, and their similarity to the vaginal microbiota composition of their sexual partner. | 1 year | 
| Penile microbiome composition after disinfection | Characterization of the penile microbiome composition using shotgun analysis, after disinfection protocol or antibiotic use. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Penile microbiome, Vaginal microbiome transplant, Male partners, Bacterial vaginosis