The Influence of Different Sample Collection and DNA Extraction Methods on the Bacterial Composition of the Gut of Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Collection of stool samples
研究概览
简要总结
The human gastrointestinal tract shelters a complex and dynamic population of microorganisms, the gut microbiota, which plays an important role in immune and metabolic homeostasis. In recent years several major diseases were linked with alterations in the gut microbiome composition.
There are known factors which can influence gut microbiata composition. For example diet is known to play a fundamental role in determining the composition of the intestinal microbiota over time. However, there are very few studies evaluating how collection and DNA isolation methods affect microbiome composition.
详细描述
An observational clinical study with 28 healthy subjects is planned to assess how different commercially available stool sampling kits and fecal DNA extraction kits influence the apparent composition of the gut microbiome. Participants will be instructed to collect stool samples at two time points separated by one week using six different methods (naïve and Zymo DNA/RNA Shield kit on dry ice as well as OMNIgene GUT, RNALater, 95% EtOH, Zymo DNA/RNA Shield at room temperature). DNA extraction from all samples will be performed using QIAamp Power Fecal (Qiagen, N. V) and ZymoBIOMICS (Zymo Research, CA.).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-60
- •Body mass index (BMI) 18,5- 29,9 kg/m2
- •Willingness to participate in the study examination and fecal sample collection process
排除标准
- •Subjects currently on medication (with the exception of contraceptives)
- •Subjects with acute or chronic disease
- •Pregnant or lactating women
- •Subjects with a history of drug or alcohol abuse
- •Subjects on a vegan diet
- •Subjects who are legal incapacitated or their circumstances do not enable the patient to fully understand the nature, significance and scope of this study.
结局指标
主要结局
Collection of stool samples
时间窗: one week
Collection of 2 stool samples in one week using different conditions DNA extraction from all samples will be performed using QIAamp Power Fecal (Qiagen, N. V) and ZymoBIOMICS (Zymo Research, CA.) to assess how different commercially available stool sampling kits and fecal DNA extraction kits influence the apparent composition of the gut microbiome
次要结局
未报告次要终点
研究者
Dr. Lajos Marko
Principal Investigator
Charite University, Berlin, Germany