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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Urinary Tract Infections
• Intervention / Treatment: Biological: ABU bladder lavage; Biological: Saline bladder lavage

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karin Andersen, MD; Phone Number: +45 21570468; Email: karin.andersen@rsyd.dk
• Study Contact Backup: Name: Lars Lund, Prof.; Email: lars.lund@rsyd.dk

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Karin U Andersen; Phone Number: +45 21570468; Email: karin.andersen@rsyd.dk
  • Odense C, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Karin Andersen, MD; Phone Number: +45 21570468; Email: karin.andersen@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients prophylatic treated with ABU; Patients with prophylactic bladder flushing with an ABU strain.	Biological: ABU bladder lavage; Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU)
Placebo Comparator: Patients control group; The control group with bladder flushing with saline solution.	Biological: Saline bladder lavage; Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of UTI events in the follow-up period	The number of prescriptions or hospital visits	1½ year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications (bleeding, pain)	Complications due to bladder lavage	1½ year
Microbiological diagnostics: Etiology, resistance	Measurements during treatment protocol	1½ year
Time to first UTI after the intervention	Symptoms and the need for medical treatment or hospitalisation	1½ year
CRF	Case report form with respect to urinary/bladder symptoms, odour, perfomancestatus ect	1½ year
Hospitalization	Hospital visit due to UTI	1½ year
Quality of life by standard Questionnaires_ICIQ-OABqol 08/04	International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol). ICIQ-OABqol is a patient-completed questionnaire evaluating the quality of life (QoL) in patients with overactive bladder. It is translated into Danish and chosen because UTI symptoms often resemble OAB symptoms. Scoring: 25-160 overall score with greater values indicating increased impact on quality of life	1½ year
O´Leary-Sant Voiding and Pain symptom score	The O'Leary-Sant Interstitial Cystitis Symptom Index is translated into Danish and chosen because UTI symptoms often resemble the bladder pain symptoms. The O'Leary-Sant instrument is comprised of a Symptom Index (score range: 0-20 points) and a Problem Index (score range: 0-16 points), each of which contains four questions related to urinary and pain symptoms. For each index, the score is calculated by summing the points for each item. Overall score with greater values indicating increased symptom severity.	1½ year
EQ-5D-5L	Questionnaire evaluating quality of life at 5 terms (mobility, self-care, usual activities, pain, discomfort and anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. EQ-5D-5L health states may be converted into a single index value. The index values, presented in country-specific value sets, are a major feature of the EQ-5D instrument, facilitating the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions.	1½ year
Creatinin	Measurements during treatment protocol in micromol/L	1½ year
Leukocytes and neutrofilocytes	Measurements during treatment protocol in 10E9/L	1½ year
Natrium and kalium	Measurements during treatment protocol in mmol/L	1½ year
CRP	Measurements during treatment protocol in mg/L	1½ year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Para-clinical findings: C reactive protein, leukocytes, Na, K, renal function (creatinine)	Measurements during treatment protocol	1½ year

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Karin Andersen, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: prophylactic; E.coli; rUTI; bladder lavage
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Communicable Diseases; Recurrence; Urinary Tract Infections
• Other Study ID Numbers: BIrUTI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No