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

Not Applicable

Recruiting

• Conditions: Recurrent Urinary Tract Infections
• Interventions: Biological: Saline bladder lavage; Biological: ABU bladder lavage

• Registration Number: NCT04846803
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-15
• Status Verified: 2024-01
• Study Start: 2024-01-09
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Primary Completion: 2025-08-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients control group	Saline bladder lavage	The control group with bladder flushing with saline solution.
Patients prophylatic treated with ABU	ABU bladder lavage	Patients with prophylactic bladder flushing with an ABU strain.

Primary Outcome Measures

Name	Time	Method
The number of UTI events in the follow-up period	1½ year	The number of prescriptions or hospital visits

Secondary Outcome Measures

Name	Time	Method
Creatinin	1½ year	Measurements during treatment protocol in micromol/L
Quality of life by standard Questionnaires_ICIQ-OABqol 08/04	1½ year	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
CRF	1½ year	Case report form with respect to urinary/bladder symptoms, odour, perfomancestatus ect
Hospitalization	1½ year	Hospital visit due to UTI
Complications (bleeding, pain)	1½ year	Complications due to bladder lavage
Microbiological diagnostics: Etiology, resistance	1½ year	Measurements during treatment protocol
Natrium and kalium	1½ year	Measurements during treatment protocol in mmol/L
EQ-5D-5L	1½ year	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.
O´Leary-Sant Voiding and Pain symptom score	1½ year	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.
Time to first UTI after the intervention	1½ year	Symptoms and the need for medical treatment or hospitalisation
Leukocytes and neutrofilocytes	1½ year	Measurements during treatment protocol in 10E9/L
CRP	1½ year	Measurements during treatment protocol in mg/L

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark

Odense University Hospital; 🇩🇰 Odense C, Denmark