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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age50+
SponsorUniversity Hospital Ostrava

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women over 50 years old

Consent to participate in the study

Willingness to take urine and blood samples according to the protocol

Disqualifiers

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

Trial population

Healthy peri- and post-menopausal female volunteers.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Blood and urine sample evaluation

    Diagnostic test

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Microbiome in healthy volunteers1 intervention

Trial outcomes

Primary outcomes

1

Microbiome alpha-diversity

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

Time frame
6 months
2

Microbiome beta-diversity

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

Time frame
6 months

Secondary outcomes

1

Correlation of microbiome alpha-diversity and serum metabolome

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

Time frame
6 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: