Trial | NCT00927316  Report issue

Title

E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)
Induced Asymptomatic E. Coli 83972 Bacteriuria in Patients With Recurrent Urinary Tract Infections and Bladder Dysfunction- is There a Protective Effect Against Recurrent Symptomatic Infections? A Blinded Placebo Controlled Cross-over Study.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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.
Study Started
Mar 31
2003
Primary Completion
Dec 31
2006
Study Completion
Dec 31
2006
Last Update
Nov 10
2009
Estimate

Biological E. coli 83972

Active arm: Intravesical inoculation (by urethral catheterization) on three subsequent days with 30 ml E. coli 83972 (100 000 cfu/ml). Placebo arm: Identical procedure but with saline, 30 ml.

Active arm Active Comparator

E. coli 83972 bacteriuria

Placebo arm Placebo Comparator

Monitoring

Criteria 

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
No Results Posted