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

Recurrent Urinary Tract Infections Clinical Trial

— BIrUTI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04846803
• Other study ID #: BIrUTI
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: January 2024
• Source: Odense University Hospital
• Contact: Karin Andersen, MD
• Phone: +45 21570468
• Email: karin.andersen[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Recurrence
• Recurrent Urinary Tract Infections
• Urinary Tract Infections

Intervention

Biological:
• ABU bladder lavage
Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU)
• Saline bladder lavage
Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with saline

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N
Denmark	Odense University Hospital	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of UTI events in the follow-up period	The number of prescriptions or hospital visits	1½ year
Secondary	Time to first UTI after the intervention	Symptoms and the need for medical treatment or hospitalisation	1½ year
Secondary	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
Secondary	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
Secondary	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
Secondary	CRF	Case report form with respect to urinary/bladder symptoms, odour, perfomancestatus ect	1½ year
Secondary	Hospitalization	Hospital visit due to UTI	1½ year
Secondary	Complications (bleeding, pain)	Complications due to bladder lavage	1½ year
Secondary	Microbiological diagnostics: Etiology, resistance	Measurements during treatment protocol	1½ year
Secondary	Creatinin	Measurements during treatment protocol in micromol/L	1½ year
Secondary	Leukocytes and neutrofilocytes	Measurements during treatment protocol in 10E9/L	1½ year
Secondary	Natrium and kalium	Measurements during treatment protocol in mmol/L	1½ year
Secondary	CRP	Measurements during treatment protocol in mg/L	1½ year