The Urinary Microbiome and Its Relationship to the Urinary and Serum Metabolome in Healthy Peri- and Postmenopausal Women

University Hospital Ostrava

Status: Not yet enrolling

Conditions: Urinary Tract Infections

Treatments: Diagnostic Test: Blood and urine sample evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT06573827

MB-001

24/RVO-FNOs/2024 (Other Grant/Funding Number)

Details and patient eligibility

About

The presented project aims to characterize the microbiome of healthy peri- and postmenopausal women and its correlation with the metabolome of urine and serum.

Full description

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women over 50 years old
• Consent to participate in the study
• Willingness to take urine and blood samples according to the protocol

Exclusion criteria

• 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

Trial design

100 participants in 1 patient group

Microbiome in healthy volunteers

Description:

Healthy volunteers willing to provide blood and urine samples for microbiome evaluation

Treatment:

Diagnostic Test: Blood and urine sample evaluation