The Urinary Microbiome and Its Relationship to the Urinary and Serum Metabolome in Healthy Peri- and Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Microbiome alpha-diversity
研究概览
简要总结
The presented project aims to characterize the microbiome of healthy peri- and postmenopausal women and its correlation with the metabolome of urine and serum.
详细描述
At the beginning of their visit to the Blood Center of the University Hospital Ostrava, blood and plasma donors will be approached by one of the authorized members of the team with information about the possibility of participating in this study. The course of the study will be explained to them in detail, including the sampling methodology, their processing, and further handling. If the subject is interested in participating in the study, they will give written informed consent to participate in the study. Subsequently, the inclusion and exclusion criteria for participation in the study will be verified. If these are not met, the subject will be excluded from the study. Furthermore, the criteria for current valid blood and urine sampling will be verified. If the conditions for valid sampling are not met and the participant is still interested in participating in the study, she will be offered a new sampling date. If the study subject fulfills the conditions of valid sampling, she will fill out a simple questionnaire, which will be used to obtain data on basic demographic characteristics. Their knowledge is essential for the correct interpretation of urine and serum test results. Blood and serum will then be collected. In justified cases, sampling can also be carried out at the Urology Department of the University Hospital Ostrava. After submitting the first sample, the participant will be asked to submit another urine and serum sample in 3-6 months. By submitting the 2nd urine and serum sample, the participant ends her participation in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women over 50 years old
- •Consent to participate in the study
- •Willingness to take urine and blood samples according to the protocol
排除标准
- •Known congenital developmental defects of the urinary tract (congenital hydronephrosis, vesicoureteral reflux, renal agenesis, and hypoplasia, multicystic and polycystic kidneys)
- •Recurrent urinary tract infections (more than 3 episodes in the last 12 months)
- •Presence of any lower-urinary tract symptoms (urgency, frequency, incontinence, stranguria, urge to urinate, weak urine stream, the feeling of post-micturition residue)
- •The presence of a foreign body in the urinary tract - urolithiasis, urinary catheter, ureteral stent
- •Acute or chronic diseases with possible influence on lower-urinary tract function
- •Medications with possible influence on lower-urinary tract function
- •Rheumatoid arthritis
- •Diabetes mellitus
结局指标
主要结局
Microbiome alpha-diversity
时间窗: 6 months
The number of bacterial species in the urine sample will be assessed.
Microbiome beta-diversity
时间窗: 6 months
Inter-individual variability in the proportion of bacterial species will be assessed.
次要结局
- Correlation of microbiome alpha-diversity and serum metabolome(6 months)
