Randomized clinical trial to evaluate the effect of a probiotic mixture of Lactobacillus plantarum on recurrent urinary tract infections in women. Secondary outcomes comprise variation in vaginal/perianal microbiota, product tolerability, safety and consumer's satisfaction with the product.
Double-blind, randomized, placebo-controlled clinical trial to determine the effect of two probiotic strains of Lactobacillus plantarum on recurrent urinary tract infections in women. Women are randomized 1:1 to one of the following study groups: one group will receive a capsule/day of the mixture of Lactobacillus plantarum in combination with cranberry, and vitamine C; and the other group will receive a capsule of placebo for 6 months. Main study outcome is the number of women who have recurrence of UTIs during th estudy compared to the placebo group. Secondary outcomes comprise the duration of disease free period, duration and severity of symptomatology, the number of symptomatic UTIs during the study, variation of Lactobacillus plantarum levels in the vaginal/perianal microbiota, product tolerability, safety and consumer's satisfaction with the product.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
106
Probiotic formulation containing Lactobacillus plantarum, cranberry and vitamine C for 6 months 1 capsule/day
Placebo composed of maltodextrin for 6 months 1 capsule/day
Fundació Puigvert
Barcelona, Barcelona, Spain
Hospital Universitario de Caceres
Cáceres, Cáceres, Spain
Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital Universitario Virgen de Arrixaca
Murcia, Murcia, Spain
Recurrence of Urninary Tract Infections (UTIs)
Number of women who have recurrence of UTIs
Time frame: month 6
Time without UTI
Time (in days) disease free until the next UTI
Time frame: month 6
Total symptomatic UTIs number
Number of symptomatic UTIs
Time frame: month 6
Change in UTI symptomatology
Change in the presence of UTI-related list of symptoms documented in CRF as "yes" or "no"
Time frame: baseline, month 6
Change in Microbiota
Change in Lactobacillus plantarum levels in the vaginal/perianal microbiota
Time frame: baseline, month 6
Incidence of Treatment-Emergent Adverse Events
Assessed by the reporting of Adverse Events
Time frame: From baseline until month 6
Satisfaction with the product
Consumer's satisfaction with the product assessed through Likert scale (ranging from very unsatisfied to very satisfied)
Time frame: Month 6
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