Status:
RECRUITING
The Genital Microbiome of Male Partners of Women with Recurrent BV Undergoing Vaginal Microbiome Transplantation
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Bacterial Vaginosis
Microbial Colonization
Eligibility:
MALE
18+ years
Phase:
NA
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 transmissio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05963711
Start Date
October 17 2022
End Date
June 1 2026
Last Update
March 19 2025
Active Locations (1)
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1
Hadassah Medical Center
Jerusalem, Israel