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

NCT ID: NCT05963711

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2026-06-30

Brief 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.

Conditions

Bacterial Vaginosis; Microbial Colonization

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

2% clindamycin cream

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Ahinoam Lev-Sagie

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hadassah Medical Center

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Ahinoam Lev Sagie, MD

Role: primary

levsagie@netvision.net.il

+972-54-4327178

Other Identifiers

0463-22-HMO

Identifier Type: -

Identifier Source: org_study_id