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

NCT04846803 | Recruiting DMC

• 1 other identifier: BIrUTI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Recurrent Urinary Tract Infections

Keywords

rUTI; E.coli; prophylactic; bladder lavage

Outcome Measures

Primary Outcomes (1)

• The number of UTI events in the follow-up period

  The number of prescriptions or hospital visits

  1½ year

Secondary Outcomes (12)

• Time to first UTI after the intervention

  1½ year

• Quality of life by standard Questionnaires_ICIQ-OABqol 08/04

  1½ year

• O´Leary-Sant Voiding and Pain symptom score

  1½ year

• EQ-5D-5L

  1½ year

• CRF

  1½ year

Study Arms (2)

Patients prophylatic treated with ABU

EXPERIMENTAL

Patients with prophylactic bladder flushing with an ABU strain.

Biological: ABU bladder lavage

Patients control group

PLACEBO COMPARATOR

The control group with bladder flushing with saline solution.

Biological: Saline bladder lavage

Interventions

ABU bladder lavage BIOLOGICAL

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

Patients prophylatic treated with ABU

Saline bladder lavage BIOLOGICAL

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

Patients control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (2)

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Odense University Hospital

Odense C, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Karin Andersen

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Andersen, MD

CONTACT

+45 21570468; karin.andersen@rsyd.dk

Lars Lund, Prof.

CONTACT

lars.lund@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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 .

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: January 9, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)