Clinical Trial of L. Reuteri in Urinary Tract Infections in Non Pregnant Women (UTIReuteri)
Urinary Tract Infections
About this trial
This is an interventional treatment trial for Urinary Tract Infections
Eligibility Criteria
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.
Sites / Locations
- Hospital General Dr. Manuel Gea Gonzalez
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Lactobacillus reuteri
Sachet with cranberry + placebo
Women in experimental branch will receive two sachets. Sachet one contains a total of 5*10^8 CFU of Lactobacillus reuteri DSM 16666 & Lactobacillus reuteri DSM 17938, mixed with maltodextrin for flowability during production. Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica.
Women in control branch will receive two sachets. Sachet one contains only Maltodextrin and sachet two contains instant cranberry drinkcomposed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica Both sachets should be emptied in a glass and mixed with 200 ml of cold water