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

August 23, 2024 updated by: University Hospital Ostrava
The presented project aims to characterize the microbiome of healthy peri- and postmenopausal women and its correlation with the metabolome of urine and serum.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • University Hospital Ostrava
        • Contact:
        • Sub-Investigator:
          • Tomáš Rychlý, MD
        • Principal Investigator:
          • Jan Krhut, prof.,MD,PhD
        • Sub-Investigator:
          • Kateřína Ryšánková, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy peri- and post-menopausal female volunteers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Microbiome in healthy volunteers
Healthy volunteers willing to provide blood and urine samples for microbiome evaluation
Diagnostic test: Blood and urine sample evaluation
Blood and urine sample evaluation will be performed in healthy female volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome alpha-diversity
Time Frame: 6 months
The number of bacterial species in the urine sample will be assessed.
6 months
Microbiome beta-diversity
Time Frame: 6 months
Inter-individual variability in the proportion of bacterial species will be assessed.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of microbiome alpha-diversity and serum metabolome
Time Frame: 6 months
The correlation of microbiome alpha-diversity and serum metabolome will be assessed.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Jan Krhut, prof.,MD,PhD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB-001
  • 24/RVO-FNOs/2024 (Other Grant/Funding Number: University Hospital Ostrava)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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