Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infection
Recurrent urinary tract infections (RUTIS) continue to be a major health problem in women and are now complicated by increasing antibiotic resistance. New preventive approaches are needed. Because most women with RUTI lack the normal protective Lactobacillus (LB) in their vaginal flora, we hypothesized that restoration of LB would reduce RUTIS. In this trail, women with recent UTI are randomized to receive either LB or placebo vaginal capsules and are followed for side effects, for colonization with LB and for occurrence of RUTI over hte next four months.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infections|
- Incidence of Urinary Tract Infection [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]Recurrent urinary tract infection after initiation of intervention. Culture-confirmed to contain uropathogen.
- Incidence of Vaginal Discharge [ Time Frame: 4 mo ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2006|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
Placebo Comparator: Placebo
Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00305227
|United States, Washington|
|Hall Health Primary Care Center, University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Ann E Stapleton, MD||University of Washington|