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

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963711
• Other study ID #: 0463-22-HMO
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: June 2026

Study information

• Verified date: July 2023
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Communicable Diseases
• Infections
• Microbial Colonization
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Penile microbiome composition after disinfection	Characterization of the penile microbiome composition using shotgun analysis, after disinfection protocol or antibiotic use.	1 year