Clinical Trial of L. Reuteri in Urinary Tract Infections in Non Pregnant Women
Clinical Trial of L. Reuteri in Urinary Tract Infections in Non Pregnant Women
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 16666 & Lactobacillus
 reuteri DSM 17938 to significantly modify the frequency of clinical or bacteriological cure
 in women with non complicated acute cystitis who receive probiotics for 12 days compared with
 the frequency in women who receive placebo.
Randomized, double blind, placebo controlled, pilot trial to evaluate the safety and efficacy
 of L. reuteri in non menopausal women with non complicated cystitis in terms of the frequency
 of clinical or bacteriological cure. Secondary outcomes will be a) time to
 clinical/laboratory relapse in at least 70% of women with non complicated acute cystitis who
 receive probiotics for 12 days compared with the time in women who receive placebo; b)
 frequency of clinical/laboratory and bacteriologic relapse in women with non complicated
 acute cystitis who receive probiotics for 12 days compared with the frequency in women who
 receive placebo, at day 30 after treatment start and c) frequency of adverse related events
 in women with non complicated acute cystitis who receive probiotics for 12 days compared with
 the frequency in women who receive placebo. In the active product we will use 5*10^8 CFU of
 Lactobacillus reuteri DSM 16666 & Lactobacillus reuteri DSM 17938 + cranberry extract. The
 control group will recibe Cranberry extract. The products will be taken twice per day,
 morning and evening.
Inclusion Criteria:

 -  Non pregnant pre menopausal women

 -  Minimum age 18 years

 -  Uncomplicated cystitis diagnosed by urine dipstick testing (nitrates +, leukocytes
 esterase

 -  and/or 105 CFU/ml or nitrates +, leukocytes esterase + and/or 102 -103 CFU/ml+
 clinical symptoms) and an evaluation of the presence of typical related symptoms.
 In particular, frequency (frequent voiding of urine), urgency (the urge to void
 immediately), dysuria (painful voiding), and/or suprapubic pain.

 -  Verbal and Written Informed Consent for participation in the study

 Exclusion Criteria:

 -  Acute cystitis symptoms for >1week before the first visit

 -  Diabetes mellitus,

 -  Congenital urinary tract abnormality

 -  Lactating women

 -  Female who intend to become pregnant during the study or within 3 months after the
 completion of the study

 -  Vaginal discharge + fever (>37.5oC)

 -  Diagnostic of sexually transmitted diseases

 -  Use of an indwelling catheter or an intermittent self-catheterisation program

 -  Presence of neurogenic bladder, or

 -  Use of any antibiotic 2 weeks before Day 1 in the study.