Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infection
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|ClinicalTrials.gov Identifier: NCT00305227|
Recruitment Status : Completed
First Posted : March 21, 2006
Results First Posted : July 4, 2014
Last Update Posted : February 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infection||Drug: Lactin-V Drug: Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infections|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
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.
- Incidence of Urinary Tract Infection [ Time Frame: 10 weeks ]Recurrent urinary tract infection after initiation of intervention. Culture-confirmed to contain uropathogen.
- Incidence of Vaginal Discharge [ Time Frame: 4 mo ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|