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

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05963711
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 43.5
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Vaginosis; Microbial Colonization	Other: chlorhexidine gluconate 4%	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: In those with BV-associated penile microbiome, a decolonization attempt will be conducted, (daily wash for 5 days with chlorhexidine gluconate 4%). if decolonization fails, an antibiotic cream will be used to eradicate BV associated bacteria.In those with BV-associated penile microbiome, a decolonization attempt will be conducted, (daily wash for 5 days with chlorhexidine gluconate 4%). if decolonization fails, an antibiotic cream will be used to eradicate BV associated bacteria.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Penile Microbiome in Partners of Women With Recurrent BV and Its Response to Decolonization Protocol
• Actual Study Start Date: Oct 17, 2022
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Jun 1, 2026

Outcome Measures

Primary Outcome Measures

1. 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.

2. Penile microbiome composition after disinfection [1 year]

   Characterization of the penile microbiome composition using shotgun analysis, after disinfection protocol or antibiotic use.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Center	Jerusalem		Israel

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahinoam Lev-Sagie, Professor, Hadassah Medical Organization
• ClinicalTrials.gov Identifier: NCT05963711
• Other Study ID Numbers: 0463-22-HMO
• First Posted: Jul 27, 2023
• Last Update Posted: Jul 27, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahinoam Lev-Sagie, Professor, Hadassah Medical Organization: Penile microbiome; Vaginal microbiome transplant; Male partners; Bacterial vaginosis
• Additional relevant MeSH terms: Vaginosis, Bacterial; Communicable Diseases; Infections; Vaginal Diseases; Chlorhexidine; Chlorhexidine gluconate; Clindamycin

Study Results

No Results Posted as of Jul 27, 2023