The goal of this clinical trial is to assess the efficacy of the probiotic Limosilactobacillus reuteri 3613 for the decrease or prevent UTI occurrence in women ages 18-65 with a confirmed medical history of recurrent uncomplicated UTIs compared to a Placebo (the study medication without the probiotic)
Adult women with a confirmed medical history of recurrent uncomplicated UTIs meeting all the eligibility criteria will be allocated in two study arms: test and placebo. Approximately 65 subjects per group will be enrolled to assure that approximately 50 subjects in each group complete the study. the study will be conducted in Ireland. The study will last approximately six month for each subject and will consist of 5 visits. The L. reuteri 3613 will be taken daily for 6 months and the frequency of UTIs will be assessed to determine the potential for the probiotic to decrease or prevent UTI occurrence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
130
Daily for 6 month
Daily for 6 month
Church &Dwight., Inc
Princeton, New Jersey, United States
RECRUITINGIncidence rate of symptomatic UTI
To evaluate in healthy women who experience recurrent UTIs, the effect of 6 months of daily supplementation of the investigational product on incidence rate of symptomatic UTIs.
Time frame: 6 months
Proportion of subjects experiencing ≥1 symptomatic UTI
Proportion of participants per product group experiencing ≥1 symptomatic UTI (as determined by urine culture) during the 6-month intervention period (from Baseline Visit \[V2\] to Final Visit \[V5\]).
Time frame: 6 months
UTI symptom severity
Change in UTI symptom severity of participants with symptomatic UTI between product groups comparing Baseline (Week 0) with scores to scores at V 5 for
Time frame: 6 months
Proportion of subjects experiencing different numbers of UTI
Proportion of participants per product group experiencing 0, 1, 2, 3, or more symptomatic UTI during the 6-month intervention period from V2 to Final V5
Time frame: 6 months
Total UTI count
Difference in total number of UTIs per group (probiotic treatment compared to placebo group) during the 6-month intervention period from V2 to Final V5
Time frame: 6 months
Time for the first UTI
Difference in time from Day 0 to the first UTI occurrence between product groups, during the 6-month intervention period from Day 0 to V5
Time frame: 6 months
Vaginal pH change
Change in vaginal pH over time from Visit 2 to Visit 5, between product groups
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Time frame: 6 months
Quality of Life change
Change in Quality of Life questionnaire using Likert scale over time from Visit 2 to Visit 5, between product groups
Time frame: 6 months