Ignite Creation Date:
2024-05-05 @ 9:35 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00927316
Status:
COMPLETED
Last Update Posted:
2009-11-10
First Post:
2009-06-22
Brief Title:
E Coli 83972 Induced Asymptomatic Bacteriuria ABU in Patients With Recurrent Urinary Tract Infections UTI
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 12 the study-team and the patients are unaware of urine culture results
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None