BIrUTI: Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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:
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The non-pathogenic bacterial strain (ABU) E.coli can overcome the most common pathogenic E.coli (UPEC) in humans.
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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, double-blind safety study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients prophylatic treated with ABU Patients with prophylactic bladder flushing with an ABU strain. |
Biological: ABU bladder lavage
Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU)
|
| Placebo Comparator: Patients control group The control group with bladder flushing with saline solution. |
Biological: Saline bladder lavage
Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with saline
|
Outcome Measures
Primary Outcome Measures
- Time to first symptomatic UTI after the intervention [1 year]
Symptoms and the need for medical treatment or hospitalisation
- The number of events (symptomatic UTIs) in the follow-up period [1 year]
The number of prescriptions or hospital visits
Secondary Outcome Measures
- Quality of life by standard Questionnaires_ICIQ-LUT [1 year]
ICIQ-LUTSqol 08/04 questionnaire evaluating quality of life (QoL) in urinary incontinent patients (overall score with greater values indicating increased symptom severity)
- Quality of life by standard Questionnaires_KAD [1 year]
ICIQ-LTCqol 12/12 Living with a long term catheter (overall score with greater values indicating increased symptom severity)
- Quality of life by standard Questionnaires_SF36 [1 year]
SF-36 (scored so that a high score defines a more favorable health state)
- Hospitalization [1 year]
Hospital visit
- Complications (bleeding, pain) [1 year]
Complications due to bladder lavage
- Microbiological diagnostics: Etiology, resistance [1 year]
Measurements during treatment protocol
- Para-clinical findings: CRP, leukocytes, U-stix, renal function (creatinine [1 year]
Measurements during treatment protocol
Other Outcome Measures
- Sexual function [1 year]
ICIQ-FLUTSsex or ICIQ-MLUTSsex evaluation of female/male sexual matters associated with their lower urinary tract symptoms and impact on quality of life (overall score with greater values indicating increased symptom severity)
- Continence_UI [1 year]
ICIQ-UI SF evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence (overall score with greater values indicating increased symptom severity)
- Lower Urinary Tract Disease [1 year]
ICIQ-FLUTS LF or ICIQ-MLUTS LF questionnaire for detailed evaluation of female/male lower urinary tract symptoms and impact on quality of life (overall score with greater values indicating increased symptom severity)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Normal investigation for lower urinary tract diseases (LUTD) including voiding diary, symptom scores, flexible cystoscopy, voiding diagram and test for residual urine.
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Failed previously treatments.
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Patients with native bladder with both spontaneous voiding, the need for clean intermittent catheter (CIC) or indwelling catheter.
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Patients with neurogenic and non-neurogenic bladder dysfunction.
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Patients with urostomy, kidney transplantation or another complicated genesis.
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Written consent.
Exclusion Criteria:
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Odense university hospital | Odense | Denmark | 5000 |
Sponsors and Collaborators
- Odense University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BIrUTI