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NCT Number: NCT04846803

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus N, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABU bladder lavage

Biological

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

Saline bladder lavage

Biological

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

Primary outcomes

  1. The number of UTI events in the follow-up period

    Time frame: 1½ year

    The number of prescriptions or hospital visits

Secondary outcomes

  1. Time to first UTI after the intervention

    Time frame: 1½ year

    Symptoms and the need for medical treatment or hospitalisation

  2. Quality of life by standard Questionnaires_ICIQ-OABqol 08/04

    Time frame: 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

  3. O´Leary-Sant Voiding and Pain symptom score

    Time frame: 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.

  4. EQ-5D-5L

    Time frame: 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.

  5. CRF

    Time frame: 1½ year

    Case report form with respect to urinary/bladder symptoms, odour, perfomancestatus ect

  6. Hospitalization

    Time frame: 1½ year

    Hospital visit due to UTI

  7. Complications (bleeding, pain)

    Time frame: 1½ year

    Complications due to bladder lavage

  8. Microbiological diagnostics: Etiology, resistance

    Time frame: 1½ year

    Measurements during treatment protocol

  9. Creatinin

    Time frame: 1½ year

    Measurements during treatment protocol in micromol/L

  10. Leukocytes and neutrofilocytes

    Time frame: 1½ year

    Measurements during treatment protocol in 10E9/L

  11. Natrium and kalium

    Time frame: 1½ year

    Measurements during treatment protocol in mmol/L

  12. CRP

    Time frame: 1½ year

    Measurements during treatment protocol in mg/L

Study contacts

Contact information is provided by the study sponsor or research team.

Karin Andersen, MD

CONTACT

[email protected]

+45 21570468

Lars Lund, Prof.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Acronym: BIrUTI

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 15, 2021
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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