Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder EmptyingMiLUTNCT07494864
Effects of Microbiological and Immunological Factors on the Lower Urinary Tract
An observational study of Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder Emptying and Asymptomatic Bacteriuria in Subjects Relying on Some Type of Catheter, run by University of Zurich at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder Emptying, Asymptomatic Bacteriuria in Subjects Relying on Some Type of Catheter, Recurrent Non-catheter Associated UTIs
- How many people
- 800 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2023to 30 Nov 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Several study arms are intended for each of the different urinary pathologies to be studied, which entail different inclusions and exclusion criteria
Who may be able to join
None listed.
Who cannot join
- 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)
- Congenital or acquired malformations of the LUT (study arm I only)
- Immunosuppressant therapy (study arm I only)
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- Need for antiviral medication (study arm I only)
- Significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known AIDS) or kidney disease; or active malignancy (except from bladder cancer) or any other condition as determined by history or laboratory investigation that could cause susceptibility to infections.
- Presence of any unstable medical or psychiatric condition (defined by the Diagnostic and Statistical Manual of Mental Disorders, Edition 4 (DSM-IV)) that could reasonably have been expected to subject the patient to unwarranted risk from participation in the study or result in a significant deterioration of the patient's clinical course.
- Drug/alcohol dependence (as defined by DSM-IV) any time during the 6 months preceding study entry.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL).
- Suspected inability to follow the procedures of the trial (e.g., language problems, psychological disorders, dementia) such that the validity of the patient's data could be compromised.
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- Patients who are unconscious, including those patients who are unconscious due to medication causing marked sedation.
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
Thomas Kessler, Prof Dr. med., +41 44 386 38 45, thomas.kessler@balgrist.ch
Lorenz Leitner, PD Dr. med., +41 44 386 39 07, lorenz.leitner@balgrist.ch
About this study
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.
- Conditions
- Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder Emptying, Asymptomatic Bacteriuria in Subjects Relying on Some Type of Catheter, Recurrent Non-catheter Associated UTIs, Acute Catheter-associated UTI (CAUTI), Recurrent Catheter-associated UTI (CAUTI), Chronic Pelvic Pain
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Healthy controls (n=20 stability study I, + n=30 diversity study, n=300 diversity study spont | Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary | |
| Arm II: Asymptomatic bacteriuria in subjects not requiring assisted bladder emptying (n=20 stability | Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary | |
| Arm III: Asymptomatic bacteriuria in subjects relying on some type of catheter for bladder emptying | Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary | |
| Arm IV: Acute non-catheter associated UTIs (n=20 stability study + n=30 diversity study) | Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary | |
| Arm V: Recurrent non-catheter associated UTIs (n=20 stability study + n=30 diversity study) | Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary | |
| Arm VI: Acute catheter-associated UTI (CAUTI) (n=20 stability study + n=30 diversity study) | Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary | |
| Arm VII: Recurrent catheter-associated UTI (CAUTI) (n=20 stability study + n=30 diversity study) | Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary | |
| Arm VIII: Chronic pelvic pain (n=20 stability study + n=30 diversity study) | Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary | |
| Arm IX: Non-neurogenic overactive bladder syndrome / LUT symptoms (n=20 stability study + n=30 diver | Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary | |
| Arm X: Non-muscle-invasive bladder cancer (n=30 diversity study + n=20 stability study) | Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jun 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder EmptyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Kessler Group, Rätsch Group, Slack Group, Boyman Group, Sunagawa Group, Zamboni Group, Loessner Group, McKinney Group, Nexus, Research Group Dirk Bumann, Research Group Christoph Dehio
- Responsible party
- Sponsor
- Investigators
- Thomas Kessler, Prof. Dr. med., Principal investigator, Universitätsklinik Balgrist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494864
- Sponsor's protocol ID
- 2023-00743
- Other IDs
- 2023
- Acronym
- MiLUT
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Microbiological and Immunological Factors on the Lower Urinary Tract
- ClinicalTrials.gov ID
- NCT07494864
- Acronym / sponsor ID
- MiLUT / 2023-00743
- Conditions
- Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder Emptying, Asymptomatic Bacteriuria in Subjects Relying on Some Type of Catheter, Recurrent Non-catheter Associated UTIs, Acute Catheter-associated UTI (CAUTI), Recurrent Catheter-associated UTI (CAUTI), Chronic Pelvic Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Kessler Group, Rätsch Group, Slack Group, Boyman Group, Sunagawa Group, Zamboni Group, Loessner Group, McKinney Group, Nexus, Research Group Dirk Bumann, Research Group Christoph Dehio
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Arm I: Healthy controls (n=20 stability study I, + n=30 diversity study, n=300 diversity study spont | – | –Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary |
| Arm II: Asymptomatic bacteriuria in subjects not requiring assisted bladder emptying (n=20 stability | – | –Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary |
| Arm III: Asymptomatic bacteriuria in subjects relying on some type of catheter for bladder emptying | – | –Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary |
| Arm IV: Acute non-catheter associated UTIs (n=20 stability study + n=30 diversity study) | – | –Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary |
| Arm V: Recurrent non-catheter associated UTIs (n=20 stability study + n=30 diversity study) | – | –Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary |
| Arm VI: Acute catheter-associated UTI (CAUTI) (n=20 stability study + n=30 diversity study) | – | –Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary |
| Arm VII: Recurrent catheter-associated UTI (CAUTI) (n=20 stability study + n=30 diversity study) | – | –Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary |
| Arm VIII: Chronic pelvic pain (n=20 stability study + n=30 diversity study) | – | –Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary |
| Arm IX: Non-neurogenic overactive bladder syndrome / LUT symptoms (n=20 stability study + n=30 diver | – | –Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary |
| Arm X: Non-muscle-invasive bladder cancer (n=30 diversity study + n=20 stability study) | – | –Bio-sampling: * Voided Urine * Vaginal / Urethral swabs * Rectal swabs * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Several study arms are intended for each of the different urinary pathologies to be studied, which entail different inclusions and exclusion criteria
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- 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)
- Congenital or acquired malformations of the LUT (study arm I only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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:
Time frame: 1 year
* 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Kessler, Prof. Dr. med. principal investigator
Universitätsklinik Balgrist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder Emptying and Asymptomatic Bacteriuria in Subjects Relying on Some Type of Catheter, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Kessler Kessler (Prof. Dr. med. ext. +41 44 386 38, thomas.kessler@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.