Urinary tract infections (UTIs) are the most common bacterial infections in women, with about 50% of women experiencing at least one UTI in their lifetime. The main pharmacological treatments of cystitis usually involve the use of antibiotics, in particular quinolones (such as ciprofloxacin and levofloxacin), fosfomycin, second-generation and third-generation cephalosporins, and b-lactam antibiotics associated with b-lactamase inhibitors.
This is a double-blinded, randomized, placebo-controlled, parallel-group study evaluating the effect of the probiotic on recurrent urinary tract infection (UTI) in adult women recently treated for UTI. Primary objective The primary objective is to evaluate the effect of oral supplementation with probiotic on the frequency of UTI during six months from start of intervention in adult women with recurrent UTI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
140
Probiotic
Clinical Trial Consultants AB
Uppsala, Sweden
To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the Frequency of Confirmed UTI in Adult Women With Recurrent UTI.
Mean number (Standard Deviation) of confirmed UTIs in adult women with recurrent UTI, during six months from start of intervention, as compared to placebo.
Time frame: 6 months
To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the -Frequency of Confirmed UTI -Time to First Relapse of UTI. -Relapse Rate -Assess the Tolerability
Mean number of confirmed UTIs during the three months intervention period, as compared to placebo. Mean number of confirmed UTIs during the three months follow-up period, as compared to placebo. Mean time from start of intervention to first relapse of UTI, as compared to placebo. Proportion of subjects (%) who experienced at least one confirmed UTI during three months from start of intervention, as compared to placebo. Proportion of subjects (%) who experienced at least one confirmed UTI during six months from start of intervention, as compared to placebo. Occurrence and frequency of Adverse Events (AEs).
Time frame: 6 month
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