Open-label, Single-arm Study to Assess the Colonization Kinetics of Clinician- Administered Vaginal Live Biotherapeutic Product Containing Multiple Strains of Lactobacillus Crispatus.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Rate of colonization with LBP isolates
研究概览
简要总结
This is an open-label, single-arm, Phase Ib trial assessing the consistency of response and colonization kinetics of a vaginally inserted live biotherapeutic intervention with optimized adherence.
详细描述
In this study investigators will enroll participants from the VIBRANT study who received active study product and test the vaginal microbiome. If a participant does not have a Lactobacillus predominant vaginal microbiome, they will re-dose with LC106 in the clinic for three days in a row. This will allow understanding of how consistent the response to LC106 is, and whether directly monitored administration improves results.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Previous participant in the VIBRANT study, randomized to active LBP
- •Nugent score 4-10
排除标准
- •Infection requiring antibiotics detected on screening labs
- •Use of oral or vaginal antibiotics in the 30 days prior to screening
- •Use of an oral or vaginal probiotic in the 30 days prior to screening
研究组 & 干预措施
Re-challenge
Administration of LC106 in clinic, for three days
干预措施: LC106 (Drug)
结局指标
主要结局
Rate of colonization with LBP isolates
时间窗: 5 weeks
Detection of at least one isolate from the LBP with at least 5% relative abundance by metagenomics, or a combination of isolates at 10% or higher.
Colonization with LBP isolates
时间窗: 5 weeks
Detection of at least one isolate from the LBP with at least 5% relative abundance by metagenomics, or a combination of isolates at 10% or higher.
次要结局
未报告次要终点
研究者
Caroline Mitchell
Associate Professor
Massachusetts General Hospital