Fecal Insult Study: An Exploratory Study to Evaluate the Microbial Consortia and Skin Barrier Function After Exposure to Artificial Fecal Irritants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Type of microbes present on skin after exposure to artificial fecal insult
研究概览
简要总结
The rationale for the study is to better understand the dynamics of skin microflora following skin barrier disruption in an adult dermatitis model. The results from this study will provide insights in the complex interaction between skin microbiome and epidermis under normal and disease conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Healthy Subjects with Fitzpatrick Skin Types I, II or III
排除标准
- •Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color
研究组 & 干预措施
Artificial Fecal Insult
protease/bile acid cocktail 200 microliters (1500 µg/ml trypsin/chymotrypsin protease mixture, 6.5 mg/ml cholic acid sodium, 6.2 mg/ml deoxycholic acid sodium, and 3.1 mg/ml chenodeoxycholic acid sodium in phosphate buffered saline)
干预措施: Artificial Fecal Insult (Other)
Artificial Fecal Insult
protease/bile acid cocktail 200 microliters (1500 µg/ml trypsin/chymotrypsin protease mixture, 6.5 mg/ml cholic acid sodium, 6.2 mg/ml deoxycholic acid sodium, and 3.1 mg/ml chenodeoxycholic acid sodium in phosphate buffered saline)
干预措施: Phosphate Buffered Saline (Other)
结局指标
主要结局
Type of microbes present on skin after exposure to artificial fecal insult
时间窗: up to 7 days
Microbes will be identified by metagenomic sequencing
Relative abundance of microbes present on skin measured in picograms of DNA
时间窗: up to 7 days
次要结局
未报告次要终点