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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06573827
Enrollment
100
Registered
2024-08-27
Start date
2024-09-01
Completion date
2028-12-31
Last updated
2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Keywords

microbiome, urinary metabolome, urinary bladder, menopause

Brief summary

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

Detailed 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.

Interventions

DIAGNOSTIC_TESTBlood and urine sample evaluation

Blood and urine sample evaluation will be performed in healthy female volunteers.

Sponsors

University Hospital Ostrava
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Microbiome alpha-diversity6 monthsThe number of bacterial species in the urine sample will be assessed.
Microbiome beta-diversity6 monthsInter-individual variability in the proportion of bacterial species will be assessed.

Secondary

MeasureTime frameDescription
Correlation of microbiome alpha-diversity and serum metabolome6 monthsThe correlation of microbiome alpha-diversity and serum metabolome will be assessed.

Countries

Czechia

Contacts

Primary ContactJiří Hynčica
jiri.hyncica@fno.cz0042059737

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026