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Effects of Microbiological and Immunological Factors on the Lower Urinary Tract

ConditionsAsymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder EmptyingAsymptomatic Bacteriuria in Subjects Relying on Some Type of CatheterRecurrent Non-catheter Associated UTIsAcute Catheter-associated UTI (CAUTI)Recurrent Catheter-associated UTI (CAUTI)Chronic Pelvic PainNon-neurogenic Overactive Bladder Syndrome / LUT SymptomsNon-muscle-invasive Bladder Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Zurich

About this trial

Millions of patients of all ages suffer worldwide from diverse urinary pathologies, such as lower urinary tract (LUT) dysfunction, bladder pain syndrome, urinary tract infections (UTIs), or bladder cancer. The research project investigates the interplay between the bladder and the microbiome. The goal is to evaluate the association of microbiological and immunological factors with lower urinary tract health in humans.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women and men aged ≥ 18 years old

Able to give informed consent for participation in the study

Willing to adhere to the study protocol for the whole trial period

Willing to undergo repetitive in-and-out single catheterization Specific inclusion criteria for the different study arms Arm I: Healthy controls Arm II: Asymptomatic bacteriuria in subjects not requiring assisted bladder emptying Arm III: Asymptomatic bacteriuria in subjects relying on some type of catheter for bladder emptying Arm IV: Acute non-catheter associated UTIs Arm V: Recurrent non-catheter associated UTIs Arm VI: Acute catheter-associated UTI Arm VII: Recurrent catheter-associated UTI Arm VIII: Chronic pelvic pain Arm IX: Non-neurogenic overactive bladder syndrome Arm X: Non-muscle-invasive bladder cancer

Disqualifiers

Current antibiotic treatment or antibiotic treatment within the last 21 days (except for study arms IV-VII)

UTI secondary to diagnosed treatable pathologies (i.e., bladder stones, enterovesical fistula etc.) and requiring specific therapy Current therapies for preventing UTIs (e.g., urine acidification, phytotherapy) or such therapies within the last 21 days (except for study arms IV-VII)

Deterioration of the upper urinary tract requiring medical intervention

Immunomodulatory therapies (apart from routine vaccination)

Trial population

Several study arms are intended for each of the different urinary pathologies to be studied, which entail different inclusions and exclusion criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

800 Participants
are grouped into 10 trial groups

10

Trial groups

See each trial group below.

Group A: Arm I: Healthy controls (n=20 stability study I, + n=30 diversity study, n=300 diversity study spont
Group B: Arm II: Asymptomatic bacteriuria in subjects not requiring assisted bladder emptying (n=20 stability
Group C: Arm III: Asymptomatic bacteriuria in subjects relying on some type of catheter for bladder emptying
Group D: Arm IV: Acute non-catheter associated UTIs (n=20 stability study + n=30 diversity study)
Group E: Arm V: Recurrent non-catheter associated UTIs (n=20 stability study + n=30 diversity study)
Group F: Arm VI: Acute catheter-associated UTI (CAUTI) (n=20 stability study + n=30 diversity study)
Group G: Arm VII: Recurrent catheter-associated UTI (CAUTI) (n=20 stability study + n=30 diversity study)
Group H: Arm VIII: Chronic pelvic pain (n=20 stability study + n=30 diversity study)
Group I: Arm IX: Non-neurogenic overactive bladder syndrome / LUT symptoms (n=20 stability study + n=30 diver
Group J: Arm X: Non-muscle-invasive bladder cancer (n=30 diversity study + n=20 stability study)

Trial outcomes

Primary outcomes

1

The primary endpoint is to evaluate differences in clinical data, immuno- and biome-markers for different LUT diseases. Data to evaluate the primary endpoints consists of:

* Clinical Patient Data To evaluate differences in disease-specific clinical data for different LUT diseases, including number of UTIs within the last year, number and name of antibiotics taken, and clinical symptoms. * Immunological Markers To evaluate differences in immunological markers for different LUT diseases, assessed by immune cell profiling of bladder biopsies and bladder washing cytology * Biome-Markers (Microbiome \& Metabolomics) To evaluate differences in biome-markers for different LUT diseases, assessed by bacterial and bacteriophage isolation, DNA extraction and 16S rDNA amplicon sequencing (including deep sequencing of the microbiome in specific cases), and metabolomic data including bacterial metabolomic expression profiles in urine and stool samples

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Zurich

Lead sponsor

Kessler Group

Collaborator

Rätsch Group

Collaborator

Slack Group

Collaborator

Boyman Group

Collaborator

Sunagawa Group

Collaborator

Zamboni Group

Collaborator

Loessner Group

Collaborator

McKinney Group

Collaborator

Nexus

Collaborator

Research Group Dirk Bumann

Collaborator

Research Group Christoph Dehio

Collaborator

Source ClinicalTrials.gov
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