The Urinary Microbiome and Its Relationship to the Urinary and Serum Metabolome in Healthy Peri- and Postmenopausal Women
NCT ID: NCT06573827
Last Updated: 2024-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2024-09-01
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Microbiome in healthy volunteers
Healthy volunteers willing to provide blood and urine samples for microbiome evaluation
Blood and urine sample evaluation
Blood and urine sample evaluation will be performed in healthy female volunteers.
Interventions
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Blood and urine sample evaluation
Blood and urine sample evaluation will be performed in healthy female volunteers.
Eligibility Criteria
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Inclusion Criteria
* Consent to participate in the study
* Willingness to take urine and blood samples according to the protocol
Exclusion Criteria
* 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
50 Years
FEMALE
Yes
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Jan Krhut, prof.,MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
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University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Mueller ER, Wolfe AJ, Brubaker L. Female urinary microbiota. Curr Opin Urol. 2017 May;27(3):282-286. doi: 10.1097/MOU.0000000000000396.
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.
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.
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.
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.
Colella M, Topi S, Palmirotta R, D'Agostino D, Charitos IA, Lovero R, Santacroce L. An Overview of the Microbiota of the Human Urinary Tract in Health and Disease: Current Issues and Perspectives. Life (Basel). 2023 Jun 30;13(7):1486. doi: 10.3390/life13071486.
Bar N, Korem T, Weissbrod O, Zeevi D, Rothschild D, Leviatan S, Kosower N, Lotan-Pompan M, Weinberger A, Le Roy CI, Menni C, Visconti A, Falchi M, Spector TD; IMI DIRECT consortium; Adamski J, Franks PW, Pedersen O, Segal E. A reference map of potential determinants for the human serum metabolome. Nature. 2020 Dec;588(7836):135-140. doi: 10.1038/s41586-020-2896-2. Epub 2020 Nov 11.
Lee-Sarwar KA, Lasky-Su J, Kelly RS, Litonjua AA, Weiss ST. Metabolome-Microbiome Crosstalk and Human Disease. Metabolites. 2020 May 1;10(5):181. doi: 10.3390/metabo10050181.
Other Identifiers
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24/RVO-FNOs/2024
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MB-001
Identifier Type: -
Identifier Source: org_study_id
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