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

Last updated: March 15, 2025
Sponsor: Hadassah Medical Organization
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sexually Transmitted Diseases (Stds)

Vaginitis

Gynecological Infections

Treatment

chlorhexidine gluconate 4%

Clinical Study ID

NCT05963711
0463-22-HMO
  • Ages > 18
  • Male
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

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

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 Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: chlorhexidine gluconate 4%
Phase:
Study Start date:
October 17, 2022
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Hadassah Medical Center

    Jerusalem,
    Israel

    Active - Recruiting

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