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Clinical Trials in Denmark / NCT04846803
Recruiting Not applicable

Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment

NCT04846803 · tracked via the Priya Life Science Denmark tracker
Sponsor
Odense University Hospital
Phase
Not applicable
Started
2024-01-09
Last updated
2025-09-18

Condition(s) studied

Recurrent Urinary Tract Infections

Investigational drug(s) / intervention(s)

ABU bladder lavageSaline bladder lavage

ABU bladder lavage: Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU)

Saline bladder lavage: Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with saline

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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. 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.

Primary outcome measure(s)

  • The number of UTI events in the follow-up period — 1½ year
    The number of prescriptions or hospital visits

Trial sites (2)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus N Denmark Recruiting
Odense University Hospital Odense C Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04846803 on ClinicalTrials.gov ↗ ← All trials in Denmark