Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Israel / NCT05963711
Recruiting Not applicable

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

NCT05963711 · tracked via the Priya Life Science Israel tracker
Sponsor
Hadassah Medical Organization
Phase
Not applicable
Started
2022-10-17
Last updated
2026-09-23

Condition(s) studied

Bacterial VaginosisMicrobial Colonization

Investigational drug(s) / intervention(s)

chlorhexidine gluconate 4%

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.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Penile microbiome composition — 1 year
    Characterization of the penile microbial communities using shotgun analysis, and their similarity to the vaginal microbiota composition of their sexual partner.
  • Penile microbiome composition after disinfection — 1 year
    Characterization of the penile microbiome composition using shotgun analysis, after disinfection protocol or antibiotic use.

Trial sites (1)

FacilityCityRegionStatus
Hadassah Medical Center Jerusalem Israel Recruiting

More Hadassah Medical Organization trials in Israel

Dipyridamole for Early-Onset Preeclampsia: A Pilot Study of Feasibility, Pharmacokinetics, and Biological Effects Starting soon
The Computerized Retraining and Functional Treatment - Group Intervention Recruiting
Testis Needle Aspiration of Sperm in Men With Azoospermia Recruiting
Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis Active, not recruiting
Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence Recruiting

Other trials for the same condition

Microbiome and Polycystic Ovaries Starting soon
Genome Driven Primary Care Clinics - an RCT Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05963711 on ClinicalTrials.gov ↗ ← All trials in Israel