Feasibility, Safety, Tolerance and Assessment of LACTIN-V Use in a Cohort of Pregnant Women at Risk of Preterm Birth
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The number of participants that demonstrate a change in vaginal colonisation during and following LACTIN-V use.
研究概览
简要总结
Preterm birth (PTB) is the primary cause of infant death worldwide. It has been shown that a vaginal microbiota deplete in Lactobacillus species is a risk factor for preterm labour. Conversely a vaginal microbiota dominated by Lactobacillus crispatus appears to be protective for these adverse outcomes. A wide range of 'over the counter' Lactobacillus spp. containing products targeted at 'vaginal health' and formulated for vaginal administration are available, but most of them do not contain vaginal species of Lactobacillus. The primary aim of this study is to determine whether vaginal supplementation with L. crispatus CTV-05 is associated with colonisation.
详细描述
Pregnant women at Queen Charlotte's and Chelsea Hospital and St Mary's Hospital London who are defined as being at a higher than background risk for preterm labour will be recruited into this study. Women at risk of pre-term labour will include those with either previous LLETZ, previous preterm birth, previous second trimester pregnancy loss or a combination of these indications.
As part of this interventional study, subjects will be offered supplementation with L. crispatus CTV-05. The preparation of LACTIN-V is administered vaginally using a specially designed applicator.
The primary aim of this study is to determine whether vaginal supplementation with L. crispatus CTV-05 is associated with colonisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Women at risk of preterm labour
- •Women referred to the prematurity clinic
- •Women with previous LLETZ (large loop excision of the transformation zone)
- •Women with previous preterm birth
- •Women with previous second trimester loss
排除标准
- •HIV positive women
- •Women who are unable to provide informed consent
- •Women aged <18
- •Women receiving antibiotic treatment within 1 week of recruitment
结局指标
主要结局
The number of participants that demonstrate a change in vaginal colonisation during and following LACTIN-V use.
时间窗: 2-4 years
Microbiological effects of LACTIN-V by laboratory analysis, next generation sequencing
次要结局
- The number of participants with treatment related adverse events following LACTIN-V supplementation in pregnant women at high risk of preterm birth.(2-4 years)
- The number of patients using LACTIN-V that go on to experience preterm birth, PPROM or cervical shortening.(2-4 years)