Study of Human Microbiota in Healthy and Pathological Conditions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count
研究概览
简要总结
The aim of the present study is to characterize the bacterial composition (microbiota) colonizing to the human body in different physio - pathological conditions (lifestyle, motor activity, surgical operations, probiotic and prebiotic consumption, antibiotic therapies, chemotherapeutic therapies), nervous and musculoskeletal diseases, gastrointestinal and metabolic disorders , oral and vaginal diseases, etc.). In particular, they will be investigate:
- the changes in the bacterial abundance
- the potential microbial interactions with the human host
- the microbial networks describing on the bacterial interactions within a specific composition of the human microbiota
详细描述
The main objective of this study is to deepen the knowledge about the bacterial communities associated to the human organism. In particular, the present study aims to evaluate how the microbiota (intestinal, cutaneous, vaginal, nasal, bronchial, breast milk, salivary, oral, etc.) is subject to quantitative and qualitative changes consequently to different events involving the human host. The project trys to highlight which microorganisms may be involved in the onset or progression of certain pathological condition, as well as to identify which bacterial genera can be more subject to variations due to specific non-pathological events.
Secondary objectives of this study are:
- To define a "healthy microbiome", that is to understand which are the main bacteria that commonly compose the human microbiome in physiological conditions, differentiating it from that present in certain pathological conditions.
- To characterize the physiological effects that bacterial changes of the human microbiota have on the host.
- To evaluate whether the use of probiotics, prebiotics, dietary and nutritional factors, cosmetics, and oral, nasal, vaginal, or pharmacological therapies of any kind can influence the microbial network of the human microbiota associated to different body districts.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •subjects suffering from neurological/behavioral diseases;
- •subjects suffering of bone diseases;
- •subjects affected of dysmetabolic / or endocrine disorders;
- •subjects with physical activities at a competitive level;
- •subjects affected of gastrointestinal disorders;
- •subjects with prolonged antibiotic therapies and undergoing surgery
排除标准
- •no use of probiotics in the month prior the sampling;
- •no use of antibiotics in the month prior the sampling;
- •no consumption of yogurt in the month prior the sampling;
研究组 & 干预措施
Neurological and behavioral disorders
Subjects with neurological or behavioral disorders such as Tourette syndrome are enrolled.
干预措施: Antibiotic therapy (Drug)
Subjects affected by bone diseases
Subjects affected by bone diseases such as infective osteomyelitis or osteoporosis are enrolled.
干预措施: Antibiotic therapy (Drug)
Prolonged antibiotic therapy
Patients subjected to prolonged antibiotic therapies and undergone a variety of surgical procedures are enrolled.
干预措施: Antibiotic therapy (Drug)
结局指标
主要结局
Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count
时间窗: Up to 24 weeks
It is a measure of the bacterial amount
次要结局
- The OTU abundances will be used to calculate an adjacency matrix based on the Spearman's correlation coefficient (rs) among different bacterial genus(up to 24 weeks)
- Shannon's index estimated on the total OTU amount(Up to 24 weeks)
- Simpson's index (D) estimated on the total OTU amount(Up to 24 weeks)
- Chao's indices estimated on the total OTU amount(Up to 24 weeks)