ABU bladder lavage
BiologicalClinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU)
NCT Number: NCT04846803
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Aarhus University Hospital, Aarhus N, Denmark
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU)
Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with saline
Time frame: 1½ year
The number of prescriptions or hospital visits
Time frame: 1½ year
Symptoms and the need for medical treatment or hospitalisation
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
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.
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.
Time frame: 1½ year
Case report form with respect to urinary/bladder symptoms, odour, perfomancestatus ect
Time frame: 1½ year
Hospital visit due to UTI
Time frame: 1½ year
Complications due to bladder lavage
Time frame: 1½ year
Measurements during treatment protocol
Time frame: 1½ year
Measurements during treatment protocol in micromol/L
Time frame: 1½ year
Measurements during treatment protocol in 10E9/L
Time frame: 1½ year
Measurements during treatment protocol in mmol/L
Time frame: 1½ year
Measurements during treatment protocol in mg/L
Contact information is provided by the study sponsor or research team.
Karin Andersen, MD
CONTACT
Lars Lund, Prof.
CONTACT
Odense University Hospital
Other
Acronym: BIrUTI
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