Actively Recruiting
The Penile Microbiome in Partners of Women with Recurrent Bacterial Vaginosis and Its Response to Decolonization Protocol
Led by Hadassah Medical Organization · Updated on 2025-03-19
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the role of the male genital microbiome in the recurrence of Bacterial Vaginosis (BV) among women undergoing vaginal microbiota transplantation. Observational evidence suggests that sexual activity is key to BV acquisition and recurrence through the exchange of bacteria between partners. Treatment of male partners has not shown benefit previously, but condom use reduces recurrence, prompting this study to investigate if disinfecting the male genital microbiome can reduce BV recurrence in female partners. Male participants will be monitored for BV-associated bacteria on the penis using molecular sequencing. If found, a decolonization protocol involving a daily wash with chlorhexidine gluconate 4% for five days will be applied. If the microbiome does not change, a second decolonization step with topical clindamycin cream twice daily for seven days will follow. Microbiome samples will be collected before and after treatment to assess changes over one year. Participants will be expected to use condoms as instructed and comply with the decolonization protocol if applicable. Researchers will assess the penile microbiome composition at baseline, after disinfection, and over a one-year period. This will help understand if male partner treatment can influence BV recurrence. Safety and adherence will be monitored throughout the study period.
CONDITIONS
Brief Title
The Genital Microbiome of Male Partners of Women with Recurrent BV Undergoing Vaginal Microbiome Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- You have a female partner who is participating in the vaginal microbiota transplantation study (NCT04517487).
- You are identified by the woman as her regular male partner.
- You are willing to use condoms as instructed by the study protocol.
- You are willing to comply with the decolonization protocol.
You will not qualify if you...
- You have a known skin disease affecting the penile skin.
- You have a known sensitivity to chlorhexidine gluconate.
- Either you or your female partner has more than one sexual partner.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several weeks depending on sampling and analysis schedule
Participants undergo sampling to identify bacterial presence associated with bacterial vaginosis and assess the penile microbiome.
1 to 2 visits depending on sampling and testing
Duration - 5 days for initial decolonization plus 7 days if repeated treatment is needed
If bacteria are identified, participants perform a daily wash with chlorhexidine gluconate 4% for 5 days as a decolonization attempt. If microbial composition does not change, an additional topical clindamycin cream treatment is applied twice daily for 7 days.
Visits for re-sampling after each treatment phase
Duration - 1 year
Participants are followed to assess changes in the penile microbiome over the course of one year after treatments.
Periodic visits for microbiome assessment during follow-up
Trial Site Locations
Total: 1 location
1
Hadassah Medical Center
Jerusalem, Israel
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
0
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