Triclosan, Triclocarban, and the Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in microbial flora
研究概览
简要总结
Triclosan (5-chloro-2 (22,4-dichlorophenoxy)phenol) is a broad-spectrum antibacterial and antifungal agent that is found in thousands of common household products, including deodorants, toothpaste, "antibacterial" soaps, cleaning products, kitchen utensils, bedding, socks, trash bags. The benefits of triclosan have not been proven except in reducing plaque and gingivitis when used in toothpaste. In this study, the investigators intend to look at whether exposure to triclosan changes the colonizing flora of the skin, gut and mouth as well as changes in certain blood hormone levels, including adipocytokines, androgens, and inflammatory markers. Changes in the gut microbiota have been associated with a variety of disease states such as inflammatory bowel disease, colorectal cancer. Additionally, reductions in the microbiome diversity have been associated with obesity.
详细描述
Hypothesis: Exposure to triclosan changes microbial flora and leads to changes in
Objectives:
- Assess diversity and quantities of microbial flora in gut, skin, mouth before, during, and after TC use
- Assess whether TC use correlates with microbial resistance
- If any, assess time to change in alterations in microbial flora
Study design:
Prospective, randomized, double-blinded, cross-over study of 20 subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health subjects
- •Age >18 years
排除标准
- •Pregnancy
- •Recent travel to the developing world (within 3 months)
- •Recent use of antibiotics (within 3 months)
- •Unwillingness to change personal care/hygiene products
- •Recent gastrointestinal illness (within 3 months)
- •Individuals who are unlikely to be available for the 10 months of the study period.
结局指标
主要结局
Changes in microbial flora
时间窗: 5 months in each phase for a total of 10 month study period
We will assess diversity and quantities of microbial flora in gut, skin, mouth before, during, and after triclosan use.
Time to alteration in flora.
时间窗: 5 months in each phase for a total of 10 month study period
We will assess time to change in alterations in microbial flora, if any.
Microbial resistance
时间窗: 5 months in each phase for a total of 10 month study period
We will assess whether triclosan use correlates with microbial resistance
次要结局
未报告次要终点
研究者
Julie Parsonnet
Professor
Stanford University