Recurrent Urinary Tract InfectionsBIrUTINCT04846803
Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment
A study testing ABU bladder lavage and Saline bladder lavage in people with Recurrent Urinary Tract Infections, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Urinary Tract Infections
- What is being tested?
- ABU bladder lavage and Saline bladder lavage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesDenmark
- Study dates
- 9 Jan 2024to 1 Dec 2027
- Phase
- Interventional
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with recurrent cystitis including 2 times of rUTI within the last 6 months or 3 times in the last 12 months, where at least 2 cultures show the same bacteria.
- Normal investigation for lower urinary tract diseases (LUTD) including voiding diary, symptom scores, flexible cystoscopy, voiding diagram and test for residual urine.
- Failed previously treatments.
- Patients with native bladder with both spontaneous voiding, the need for clean intermittent catheter (CIC) or indwelling catheter.
- Patients with neurogenic and non-neurogenic bladder dysfunction.
- Patients with urostomy, kidney transplantation or another complicated genesis.
- Written consent.
Who cannot join
- Malignancy in the urinary tract, kidney-, ureteral- or bladder stones, age < 18 years, pregnancy, breastfeeding. Patients in ongoing orally antibiotic treatment. Not able to speak or understand Danish.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lars Lund, Prof. contact
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Karin U Andersen, +45 21570468, karin.andersen@rsyd.dk
- Recruiting
Odense University Hospital
Odense C, 5000
Karin Andersen, MD, +45 21570468, karin.andersen@rsyd.dk
About this study
Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies.
We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.
Read the detailed description
Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies.
We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.
Claim to be investigated:
- The non-pathogenic bacterial strain (ABU) E.coli can overcome the most common pathogenic E.coli (UPEC) in humans.
- ABU can be used for preventive treatment in patients with recurrent urinary tract infections.
Clinical effect of preventive treatment (prophylactic treatment) with the non-pathogenic bacterial strain (ABU) in a selected group of patients with recurrent cystitis: A clinical, placebo-controlled, triple-blinded study.
- Conditions
- Recurrent Urinary Tract Infections
- Being tested
- ABU bladder lavage, Saline bladder lavage
- Keywords
- rUTI, E.coli, prophylactic, bladder lavage
- Medical subject headings
- Urinary Tract Infections, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABU bladder lavageBiological
Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU)
Saline bladder lavageBiological
Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with saline
| Study group | Role | What they receive |
|---|---|---|
| Patients prophylatic treated with ABU | Experimental | Patients with prophylactic bladder flushing with an ABU strain. Receives: Biological: ABU bladder lavage |
| Patients control group | Placebo comparator | The control group with bladder flushing with saline solution. Receives: Biological: Saline bladder lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of UTI events in the follow-up period
The number of prescriptions or hospital visits
Measured: 1½ year
Secondary outcomes (12)
Time to first UTI after the intervention
Symptoms and the need for medical treatment or hospitalisation
Measured: 1½ year
Quality of life by standard Questionnaires_ICIQ-OABqol 08/04
International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol).
ICIQ-OABqol is a patient-completed questionnaire evaluating the quality of life (QoL) in patients with overactive bladder. It is translated into Danish and chosen because UTI symptoms often resemble OAB symptoms.
Scoring: 25-160 overall score with greater values indicating increased impact on quality of life
Measured: 1½ year
O´Leary-Sant Voiding and Pain symptom score
The O'Leary-Sant Interstitial Cystitis Symptom Index is translated into Danish and chosen because UTI symptoms often resemble the bladder pain symptoms. The O'Leary-Sant instrument is comprised of a Symptom Index (score range: 0-20 points) and a Problem Index (score range: 0-16 points), each of which contains four questions related to urinary and pain symptoms. For each index, the score is calculated by summing the points for each item. Overall score with greater values indicating increased symptom severity.
Measured: 1½ year
EQ-5D-5L
Questionnaire evaluating quality of life at 5 terms (mobility, self-care, usual activities, pain, discomfort and anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. EQ-5D-5L health states may be converted into a single index value. The index values, presented in country-specific value sets, are a major feature of the EQ-5D instrument, facilitating the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions.
Measured: 1½ year
CRF
Case report form with respect to urinary/bladder symptoms, odour, perfomancestatus ect
Measured: 1½ year
Hospitalization
Hospital visit due to UTI
Measured: 1½ year
Complications (bleeding, pain)
Complications due to bladder lavage
Measured: 1½ year
Microbiological diagnostics: Etiology, resistance
Measurements during treatment protocol
Measured: 1½ year
Creatinin
Measurements during treatment protocol in micromol/L
Measured: 1½ year
Leukocytes and neutrofilocytes
Measurements during treatment protocol in 10E9/L
Measured: 1½ year
Natrium and kalium
Measurements during treatment protocol in mmol/L
Measured: 1½ year
CRP
Measurements during treatment protocol in mg/L
Measured: 1½ year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start9 Jan 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Inclusion with 6 months observation (standard treatment). Randomisation in ratio 3:1 for treatment initiation at baseline. 1. Patients with prophylactic bladder flushing with an ABU strain. 2. The control group with saline bladder flushing .
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Andersen, Odense University Hospital
- Investigators
- Karin Andersen, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846803
- Sponsor's protocol ID
- BIrUTI
- Acronym
- BIrUTI
- Status last verified
- Sep 2025
- First submitted
- 12 Apr 2021
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment
- ClinicalTrials.gov ID
- NCT04846803
- Acronym / sponsor ID
- BIrUTI / BIrUTI
- Conditions
- Recurrent Urinary Tract Infections
- Keywords
- rUTI, E.coli, prophylactic, bladder lavage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Apr 2021 (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.
Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies.
We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.
Detailed description
Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies.
We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.
Claim to be investigated:
- The non-pathogenic bacterial strain (ABU) E.coli can overcome the most common pathogenic E.coli (UPEC) in humans.
- ABU can be used for preventive treatment in patients with recurrent urinary tract infections.
Clinical effect of preventive treatment (prophylactic treatment) with the non-pathogenic bacterial strain (ABU) in a selected group of patients with recurrent cystitis: A clinical, placebo-controlled, triple-blinded study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Inclusion with 6 months observation (standard treatment). Randomisation in ratio 3:1 for treatment initiation at baseline. 1. Patients with prophylactic bladder flushing with an ABU strain. 2. The control group with saline bladder flushing .
| Arm | Type | Receives |
|---|---|---|
| Patients prophylatic treated with ABU | Experimental | Biological: ABU bladder lavagePatients with prophylactic bladder flushing with an ABU strain. |
| Patients control group | Placebo comparator | Biological: Saline bladder lavageThe control group with bladder flushing with saline solution. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with recurrent cystitis including 2 times of rUTI within the last 6 months or 3 times in the last 12 months, where at least 2 cultures show the same bacteria.
- Normal investigation for lower urinary tract diseases (LUTD) including voiding diary, symptom scores, flexible cystoscopy, voiding diagram and test for residual urine.
- Failed previously treatments.
- Patients with native bladder with both spontaneous voiding, the need for clean intermittent catheter (CIC) or indwelling catheter.
- Patients with neurogenic and non-neurogenic bladder dysfunction.
Key exclusion criteria (1 listed)
- Malignancy in the urinary tract, kidney-, ureteral- or bladder stones, age < 18 years, pregnancy, breastfeeding. Patients in ongoing orally antibiotic treatment. Not able to speak or understand Danish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABU bladder lavageClinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU) | Biological | Patients prophylatic treated with ABU |
| Saline bladder lavageClinical effect of preventive treatment (prophylactic treatment) - bladder lavage with saline | Biological | Patients control group |
Primary outcome
The number of UTI events in the follow-up period
Time frame: 1½ year
The number of prescriptions or hospital visits
12 secondary outcomes
Time to first UTI after the intervention
Time frame: 1½ year
Quality of life by standard Questionnaires_ICIQ-OABqol 08/04
Time frame: 1½ year
O´Leary-Sant Voiding and Pain symptom score
Time frame: 1½ year
EQ-5D-5L
Time frame: 1½ year
CRF
Time frame: 1½ year
Hospitalization
Time frame: 1½ year
Complications (bleeding, pain)
Time frame: 1½ year
Microbiological diagnostics: Etiology, resistance
Time frame: 1½ year
Creatinin
Time frame: 1½ year
Leukocytes and neutrofilocytes
Time frame: 1½ year
Natrium and kalium
Time frame: 1½ year
CRP
Time frame: 1½ year
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 18 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Lars Lund, Prof. contact
Karin Andersen principal investigator
University of Southern Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABU bladder lavage and Saline bladder lavage in people with Recurrent Urinary Tract Infections, run by Odense University Hospital at 2 sites in Denmark.
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 7 inclusion and 1 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 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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. Some participants in this study may receive a placebo. 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 Karin Andersen, MD (+45 21570468, karin.andersen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of UTI events in the follow-up period (time frame: 1½ 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 18 Sep 2025.