RecruitingNot ApplicableNCT04846803

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


Sponsor

Odense University Hospital

Enrollment

80 participants

Start Date

Jan 9, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria7

  • 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 Criteria1

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALABU bladder lavage

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

BIOLOGICALSaline bladder lavage

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


Locations(2)

Aarhus University Hospital

Aarhus N, Denmark

Odense University Hospital

Odense C, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04846803


Related Trials