Urinary tract infections (UTIs) are the most common bacterial infections in women. 50% of women experiencing at least one UTI in their lifetime with an annual prevalence of 0.5-0.7%. An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strains on the urinary tract microbiota in participants with recurrent urinary tract infection (rUTI). The study duration will be 6 and a half months, including 6 months product intake. Participants will be randomly assigned to one of the three study groups: control group with placebo administration, probiotic administration group (1 dose) and probiotic administration group (2 doses).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
1 capsule of probiotic (Lactobacillus CECT 9422 + Bifidobacterium CECT 30257) every 12 hours for 6-months.
1 capsule of probiotic + 1 capsule of placebo per day for 6-months.
1 capsule of placebo every 12 hours for 6-months.
Hospital La Moraleja
Madrid, Spain
Hospital La Zarzuela
Madrid, Spain
Hospital San Francisco de Asís
Madrid, Spain
Evaluate the number of participants with a positive urine culture
The number of participants with a positive urine culture will be compared between groups of treatment.
Time frame: Before intervention
Evaluate the number of participants with a positive urine culture
The number of participants with a positive urine culture will be compared between groups of treatment.
Time frame: After 3 months of intervention.
Evaluate the number of participants with a positive urine culture
The number of participants with a positive urine culture will be compared between groups of treatment.
Time frame: After 6 months of intervention.
Evaluate the total bacterial count in urine samples.
The total bacterial count in urine samples will be compared between groups of treatment.
Time frame: Before intervention
Evaluate the total bacterial count in urine samples.
The total bacterial count in urine samples will be compared between groups of treatment.
Time frame: After 3 months of intervention
Evaluate the total bacterial count in urine samples.
The total bacterial count in urine samples will be compared between groups of treatment.
Time frame: After 6 months of intervention
Number of UTI episodes
Time frame: After 3 and 6 months of intervention.
Infection free participants (%)
Time frame: After 6 months of intervention.
Elapsed time until the 1st episode of UTI.
Time frame: After 6 months of intervention.
Elapsed time between the 1st and 2nd episode of UTI.
Time frame: After 6 months of intervention.
Elapsed time between the 2nd and 3rd episode of UTI.
Time frame: After 6 months of intervention.
Duration of UTI episodes.
Time frame: After 6 months of intervention.
The number of participants which associate sexual activity with the UTI episodes
The number of participants which associate sexual activity with the apperance of an UTI episode will be counted and compared between groups.
Time frame: After 6 months of intervention.
Number of present symptoms during new UTI episodes.
Time frame: After 6 months of intervention.
Number of participants with dysuria.
Time frame: After 6 months of intervention.
Duration of dysuria.
Time frame: After 6 months of intervention.
Number of participants with pollakiuria
Time frame: After 6 months of intervention.
Duration of pollakiuria
Time frame: After 6 months of intervention.
Number of participants with urinary urgency.
Time frame: After 6 months of intervention.
Duration of urinary urgency.
Time frame: After 6 months of intervention.
Number of participants with tenesmus.
Time frame: After 6 months of intervention.
Duration of tenesmus.
Time frame: After 6 months of intervention.
Number of participants with hematuria.
Time frame: After 6 months of intervention.
Duration of hematuria
Time frame: After 6 months of intervention.
Number of participants with dyspareunia
Time frame: After 6 months of intervention.
Duration of dyspareunia
Time frame: After 6 months of intervention.
Number of participants with pelvic pain
Time frame: After 6 months of intervention.
Duration of pelvic pain
Time frame: After 6 months of intervention.
Number of participants with fever (Tª ≥ 38ºC).
Time frame: After 6 months of intervention.
Duration of fever (Tª ≥ 38ºC).
Time frame: After 6 months of intervention.
Number of participants with cloudy and smelly urine
Time frame: After 6 months of intervention.
Duration of cloudy and smelly urine
Time frame: After 6 months of intervention.
Number of antibiotics administered for the UTI episode.
Time frame: After 6 months of intervention.
Duration of antibiotic treatment for the UTI episode.
Time frame: After 6 months of intervention.
Number of antibiotic treatments administered during new UTI episodes.
Time frame: After 6 months of intervention.
Duration of antibiotic treatments administered during new UTI episodes.
Time frame: After 6 months of intervention.
Microbiome composition of stool samples determined by 16S sequencing.
The composition of fecal microbiome will be compared between treatments group and time
Time frame: After 6 months of intervention.
Microbiota composition of urine samples determined by culture techniques.
The composition of urine microbiota will be compared between treatments group and time.
Time frame: After 6 months of intervention.
Metabolomic profile of urine samples.
Time frame: After 6 months of intervention.
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