Effects of IV Omadacycline on Gut Microbiome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Phylum Level Mean Proportional Relative Abundance
研究概览
简要总结
Given the clinical need to improve upon current antibiotic regimens for the treatment of C. difficile infection with a particular focus on the impact of therapies on gut microbiome, this study proposes to characterize the impact of Intravenous (IV) omadacycline on gut microbiome of healthy volunteers.
详细描述
The plan to enroll eight healthy volunteers between the ages of 18 and 40 years and without history of cardiovascular, gastrointestinal, hepatic, or renal disease to receive 5 days of intravenous omadacycline followed by 5 days of oral omadacycline. Stool and saliva samples will be collected at pre-specified times and analyzed to characterize the impact of IV omadacycline on gut microbiome.
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
- All
- 接受健康志愿者
- 是
入选标准
- •18-40 years of age
- •Willing and able to comply with all study procedures
- •Considered healthy without history of cardiovascular, gastrointestinal, hepatic, or renal disease
- •males or females - females of child bearing potential must agree to use a highly effective contraception during the study and for at least 7 days after the last dose of omadacycline
排除标准
- •Consumed probiotics within 30 days before enrollment
- •Consumed antibiotics within 90 days prior to enrollment
- •Known hypersensitivity to omadacycline or tetracycline-class antibiotics
- •pregnant or breastfeeding
- •in the opinion of the investigator is experiencing signs or symptoms of acute illness that increase the risk of adverse effects from participating in the study
- •previously participated in the study
研究组 & 干预措施
Intravenous (IV) Omadacycline
All participants will receive 5 days of IV omadacycline followed by 5 days of oral omadacycline
干预措施: Omadacycline Injection (Drug)
结局指标
主要结局
Phylum Level Mean Proportional Relative Abundance
时间窗: Day 10
In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity.
Bacterial DNA Per Gram of Stool
时间窗: End of Therapy up to Day 10
nanograms (ng) per gram of stool for bacterial DNA
Order Level Mean Proportional Relative Abundance
时间窗: Day 30
Order Level Mean Proportional Relative Abundance - Relative abundance % for order
次要结局
未报告次要终点