E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)

Region Skane

Status: Completed

Conditions: Urinary Tract Infection

Treatments: Biological: E. coli 83972

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00927316

RTP-A2003

Details and patient eligibility

About

This study tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli 83972) protect against symptomatic urinary tract infections in individuals with bladder emptying dysfunctions and prone to recurrent infection episodes? The study is performed using a double-blind randomized study protocol with a cross-over, with re-inoculations being patient-blinded (phase 1). After patients have fulfilled the cross-over, those who have had bacteriuria or placebo-periods < 12 months will be subjected to additional patient blinded inoculations (phase 2). During the entire study (phase 1+2) the study-team and the patients are unaware of urine culture results.

Enrollment: 30 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recurrent UTI
• Bladder emptying dysfunction
• Optimal conservative treatment incl. clean intermittent catheterization
• Capable of "self reporting of UTI episodes"

Exclusion criteria

• Malignant disease
• Immunosuppression
• Recurrent pyelonephritis
• Abnormalities within upper urinary tract, including renal stones and poor kidney function

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Active arm

Active Comparator group

Description:

E. coli 83972 bacteriuria

Treatment:

Biological: E. coli 83972

Placebo arm

Placebo Comparator group

Description:

Monitoring

Treatment:

Biological: E. coli 83972