The Penile Microbiome in Partners of Women with Recurrent BV and Its Response to Decolonization Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Penile microbiome composition
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Penile microbiome composition
时间窗: 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
时间窗: 1 year
Characterization of the penile microbiome composition using shotgun analysis, after disinfection protocol or antibiotic use.
次要结局
未报告次要终点
研究者
Ahinoam Lev-Sagie
Professor
Hadassah Medical Organization