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NCT Number: NCT06573827

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

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

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location contact

Jan Krhut, prof.,MD,PhD

PRINCIPAL_INVESTIGATOR

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Kateřína Ryšánková, MD,PhD

SUB_INVESTIGATOR

Tomáš Rychlý, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and urine sample evaluation

Diagnostic Test

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

Primary outcomes

  1. Microbiome alpha-diversity

    Time frame: 6 months

    The number of bacterial species in the urine sample will be assessed.

  2. Microbiome beta-diversity

    Time frame: 6 months

    Inter-individual variability in the proportion of bacterial species will be assessed.

Secondary outcomes

  1. Correlation of microbiome alpha-diversity and serum metabolome

    Time frame: 6 months

    The correlation of microbiome alpha-diversity and serum metabolome will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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