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Recruiting NCT04846803

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

No phase Interventional Recurrent Urinary Tract Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ABU bladder lavage, Saline bladder lavage.
Who it may be relevant to
Registry conditions: Recurrent Urinary Tract Infections. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • The number of UTI events in the follow-up period [Time frame: 1½ year]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Denmark · 2 centers
  • Aarhus University Hospital — Aarhus N
  • Odense University Hospital — Odense C

Identifiers

NCT: NCT04846803 · BIrUTI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗