Clinical trial NCT04846803: Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment
Official title: Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Urinary Tract Infections
Keywords: rUTI
E.coli
prophylactic
bladder lavage
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 .
Primary purpose: PREVENTION

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.

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.

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.

Primary outcomes:
measure: The number of UTI events in the follow-up period
timeFrame: 1½ year
Secondary outcomes:
measure: Time to first UTI after the intervention
timeFrame: 1½ year
measure: Quality of life by standard Questionnaires_ICIQ-OABqol 08/04
timeFrame: 1½ year
measure: O´Leary-Sant Voiding and Pain symptom score
timeFrame: 1½ year
measure: EQ-5D-5L
timeFrame: 1½ year
measure: CRF
timeFrame: 1½ year
measure: Hospitalization
timeFrame: 1½ year
measure: Complications (bleeding, pain)
timeFrame: 1½ year
measure: Microbiological diagnostics: Etiology, resistance
timeFrame: 1½ year
measure: Creatinin
timeFrame: 1½ year
measure: Leukocytes and neutrofilocytes
timeFrame: 1½ year
measure: Natrium and kalium
timeFrame: 1½ year
measure: CRP
timeFrame: 1½ year
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: University of Southern Denmark
name: Karin Andersen
role: PRINCIPAL_INVESTIGATOR
References: