Urinary Tract Infections
Conditions
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTLactobacillus reuteri
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. The products will be taken twice per day, morning and evening. The daily dose in the active group will be at least 5\*10\^8 CFU of L.reuteri DSM16666 and L. reuteri DSM17938), PAC-A and zinc
DIETARY_SUPPLEMENTSachet with cranberry + placebo
Sachet one contains placebo for probiotics (maltodextrin). Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica.
Sponsors
Innovacion y Desarrollo de Estrategias en Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized controlled trial, double blind allocation concealment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical and bacteriological cure | 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical or bacteriological relapse | 30 days | 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 |
| Adverse events | 14 days | • 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 |
Countries
Mexico
Outcome results
None listed