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Probiotic
Applicator with LACTIN-V Treatment for Urinary Tract Infection
Phase 2 & 3
Waitlist Available
Led By Ann E Stapleton, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
pre-menopausal women
present with an acute, uncomplicated, culture confirmed UTI, defined as dysuria, urgency and/or frequency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 2, 6, 10, 14 and18
Awards & highlights
Study Summary
The purpose of this research is to see whether LACTIN-V (Lactobacillus crispatus CTV-05) is an effective method of preventing recurrent urinary tract infections (UTI's) and to learn the side effects of LACTIN-V. LACTIN-V is a vaginal applicator that contains Lactobacillus crispatus, an organism found naturally in the vaginas of healthy women. Lactobacillus bacteria are thought to help prevent other bacteria such as E. coli from causing UTI's. This is a double blind study comparing active product to a placebo (inactive vaginal applicator without any medicine).
Eligible Conditions
- Urinary Tract Infection
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 0, 2, 6, 10, 14 and18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 2, 6, 10, 14 and18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
UTI Incidence as Described Below, Over the 16 Week Study Period Following Randomization, in the LACTIN-V Treatment Group (Group A) as Compared to the Placebo Group (Group B).
Secondary outcome measures
Parameter of Vaginal Colonization
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Applicator with LACTIN-V TreatmentActive Control1 Intervention
Vaginal applicator containing Lactobacillus crispatus CTV-05
Group II: Applicator with PlaceboPlacebo Group1 Intervention
Inactive vaginal applicator without any drug
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,732 Previous Clinical Trials
1,841,925 Total Patients Enrolled
5 Trials studying Urinary Tract Infection
1,364 Patients Enrolled for Urinary Tract Infection
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,348 Previous Clinical Trials
4,314,705 Total Patients Enrolled
7 Trials studying Urinary Tract Infection
1,542 Patients Enrolled for Urinary Tract Infection
Ann E Stapleton, MDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Urinary Tract Infection
100 Patients Enrolled for Urinary Tract Infection
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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