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

July 26, 2023 updated by: Ahinoam Lev-Sagie, Hadassah Medical Organization

The Penile Microbiome in Partners of Women With Recurrent BV and Its Response to Decolonization Protocol

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Hadassah Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penile microbiome composition
Time Frame: 1 year
Characterization of the penile microbial communities using shotgun analysis, and their similarity to the vaginal microbiota composition of their sexual partner.
1 year
Penile microbiome composition after disinfection
Time Frame: 1 year
Characterization of the penile microbiome composition using shotgun analysis, after disinfection protocol or antibiotic use.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0463-22-HMO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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