Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- BV recurrence rate
研究概览
简要总结
The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis.
详细描述
The volunteers will be recruited from the women who come to the hospital to do the bacterial vaginosis test. After being informed about the potential risks, each volunteer giving written informed consent will be asked to complete a questionnaire.
Then, posterior fornix of vagina secretions will be taken from each volunteer to perform 16S rRNA gene sequencing microecology assessment , Clue cell detection and amine test.
After 2weeks ,1 month ,3 months,6 months,12 monthssince the entry, each volunteer will be asked to go back to research center to do the same sampling and examination as previously did in entry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1. History of sexual behaviour 2.18-55 years old
- •Women were diagnosed as bacterial vaginosis
排除标准
- •During pregnancy, or within 8 weeks after delivery;
- •presence of systemic diseases (such as SLE, malignant tumors, etc.)
结局指标
主要结局
BV recurrence rate
时间窗: month 12
Primary Outcome Measure
次要结局
- BV recurrence rate(2 weeks，month 1，month 3、month 6)
- vaginal secretions 16s rRNA gene sequencing(2 weeks，month 1，month 3、month 6、month 12)
研究者
Hongwei Zhou
Professor
Zhujiang Hospital