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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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 2, 6, 10, 14 and18

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 2, 6, 10, 14 and18
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 2, 6, 10, 14 and18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
1,822 Previous Clinical Trials
1,914,746 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
2,453 Previous Clinical Trials
4,332,735 Total Patients Enrolled
6 Trials studying Urinary Tract Infection
1,472 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
~3 spots leftby Dec 2025
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