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

NCT ID: NCT04846803

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2027-12-01

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.

Conditions

Recurrent Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Patients prophylatic treated with ABU

Patients with prophylactic bladder flushing with an ABU strain.

Group Type: EXPERIMENTAL

ABU bladder lavage

Intervention Type: BIOLOGICAL

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

Patients control group

The control group with bladder flushing with saline solution.

Group Type: PLACEBO_COMPARATOR

Saline bladder lavage

Intervention Type: BIOLOGICAL

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

Interventions

ABU bladder lavage

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

Intervention Type: BIOLOGICAL

Saline bladder lavage

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karin Andersen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karin Andersen

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

Aarhus University Hospital

Aarhus N, , Denmark

Site Status: RECRUITING

Odense University Hospital

Odense C, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Karin Andersen, MD

Role: CONTACT

karin.andersen@rsyd.dk

+45 21570468

Lars Lund, Prof.

Role: CONTACT

lars.lund@rsyd.dk

Facility Contacts

Karin U Andersen

Role: primary

karin.andersen@rsyd.dk

+45 21570468

Karin Andersen, MD

Role: primary

karin.andersen@rsyd.dk

+45 21570468

Other Identifiers

BIrUTI

Identifier Type: -

Identifier Source: org_study_id