The Urinary Microbiome and Its Relationship to the Urinary and Serum Metabolome in Healthy Peri- and Postmenopausal Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood and urine sample evaluation.
- Who it may be relevant to
- Registry conditions: Urinary Tract Infections. Basic parameters: from 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 test Blood and urine sample evaluation
Blood and urine sample evaluation will be performed in healthy female volunteers.
Primary outcome measures
- Microbiome alpha-diversity [Time frame: 6 months]
- Microbiome beta-diversity [Time frame: 6 months]
Secondary outcome measures (1)
- Correlation of microbiome alpha-diversity and serum metabolome [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
Czechia · 1 center
- University Hospital Ostrava — Ostrava
Publications
- Cho I, Blaser MJ. The human microbiome: at the interface of health and disease. Nat Rev Genet. 2012 Mar 13;13(4):260-70. doi: 10.1038/nrg3182. PMID 22411464
- Turnbaugh PJ, Ley RE, Hamady M, Fraser-Liggett CM, Knight R, Gordon JI. The human microbiome project. Nature. 2007 Oct 18;449(7164):804-10. doi: 10.1038/nature06244. PMID 17943116
- Monsen T, Ryden P. Flow cytometry analysis using sysmex UF-1000i classifies uropathogens based on bacterial, leukocyte, and erythrocyte counts in urine specimens among patients with urinary tract infections. J Clin Microbiol. 2015 Feb;53(2):539-45. doi: 10.1128/JCM.01974-14. Epub 2014 Dec 3. PMID 25472486
- Mueller ER, Wolfe AJ, Brubaker L. Female urinary microbiota. Curr Opin Urol. 2017 May;27(3):282-286. doi: 10.1097/MOU.0000000000000396. PMID 28234750
- Morand A, Cornu F, Dufour JC, Tsimaratos M, Lagier JC, Raoult D. Human Bacterial Repertoire of the Urinary Tract: a Potential Paradigm Shift. J Clin Microbiol. 2019 Feb 27;57(3):e00675-18. doi: 10.1128/JCM.00675-18. Print 2019 Mar. PMID 30404941
- Salabura A, Luniewski A, Kucharska M, Myszak D, Dolegowska B, Ciechanowski K, Kedzierska-Kapuza K, Wojciuk B. Urinary Tract Virome as an Urgent Target for Metagenomics. Life (Basel). 2021 Nov 19;11(11):1264. doi: 10.3390/life11111264. PMID 34833140
- Nelson DE, Dong Q, Van der Pol B, Toh E, Fan B, Katz BP, Mi D, Rong R, Weinstock GM, Sodergren E, Fortenberry JD. Bacterial communities of the coronal sulcus and distal urethra of adolescent males. PLoS One. 2012;7(5):e36298. doi: 10.1371/journal.pone.0036298. Epub 2012 May 11. PMID 22606251
- Antunes-Lopes T, Vale L, Coelho AM, Silva C, Rieken M, Geavlete B, Rashid T, Rahnama'i SM, Cornu JN, Marcelissen T; EAU Young Academic Urologists (YAU) Functional Urology Working Group. The Role of Urinary Microbiota in Lower Urinary Tract Dysfunction: A Systematic Review. Eur Urol Focus. 2020 Mar 15;6(2):361-369. doi: 10.1016/j.euf.2018.09.011. Epub 2018 Sep 28. PMID 30270128
Identifiers
NCT: NCT06573827 · MB-001 · 24/RVO-FNOs/2024