Vaginal Flora Transplantation for Recurrent Bacterial Vaginosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- relief of bacterial vaginosis
研究概览
简要总结
Bacterial vaginosis (BV) is the most common vaginal infection in women. It is caused by a vaginal bacterial imbalance. Treatment with antibiotics is the standard of care but there is a high rate of recurrence. Almost half of women successfully treated suffer a recurrence within three months. Complications include risk factors for premature birth, increased transmission of sexually transmitted diseases and higher risk for carcinoma of cervix. The investigators proposed study is a cost effective treatment based on returning the normal microbial balance to the vagina. The investigators propose to transfer normal vaginal flora from healthy individuals to women with BV and thus restore normal vaginal flora and cure this disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •recurrent BV (4 or more incidences in the past year)
- •recurrence of BV in less than 2 months of antibiotic treatment or need for prophylactic antibiotic
- •3/4 Amsel criteria and Nugent criteria greater or equal to 7
排除标准
- •pregnancy or planned pregnancy during the study period
- •other known diseases
- •carriers of Hep B and C
- •HIV or syphilis positive
研究组 & 干预措施
recurrent bacterial vaginitis
干预措施: vaginal flora transplant (Biological)
结局指标
主要结局
relief of bacterial vaginosis
时间窗: 12 month
Clinical cure, i.e., absence of vaginal discharge and malodor
次要结局
- Laboratory parameters(12 months)