Urinary Tract Infections
Conditions
Keywords
Probiotics, Women health, Microbiota
Brief summary
Randomized clinical trial to evaluate the effect of a probiotic mixture of Lactobacillus plantarum on recurrent urinary tract infections in women. Secondary outcomes comprise variation in vaginal/perianal microbiota, product tolerability, safety and consumer's satisfaction with the product.
Detailed description
Double-blind, randomized, placebo-controlled clinical trial to determine the effect of two probiotic strains of Lactobacillus plantarum on recurrent urinary tract infections in women. Women are randomized 1:1 to one of the following study groups: one group will receive a capsule/day of the mixture of Lactobacillus plantarum in combination with cranberry, and vitamine C; and the other group will receive a capsule of placebo for 6 months. Main study outcome is the number of women who have recurrence of UTIs during th estudy compared to the placebo group. Secondary outcomes comprise the duration of disease free period, duration and severity of symptomatology, the number of symptomatic UTIs during the study, variation of Lactobacillus plantarum levels in the vaginal/perianal microbiota, product tolerability, safety and consumer's satisfaction with the product.
Interventions
DIETARY_SUPPLEMENTFood supplement
Probiotic formulation containing Lactobacillus plantarum, cranberry and vitamine C for 6 months 1 capsule/day
DIETARY_SUPPLEMENTPlacebo
Placebo composed of maltodextrin for 6 months 1 capsule/day
Sponsors
AB Biotics, SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Probiotic and placebo products will be provided in identical packaging
Intervention model description
Double-blind, randomized, placebo controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women over 18 years of age. * Women who have had at least one episode of UTI in the past 4 months * Women with a well-documented history of recurrent UTIs: ≥2 infections in the past 6 months or ≥3 in the past 12 months. * Women who have been treated with an antibiotic regimen for each episde of UTI * Recurrence due to reinfection, not relapse: multiple infections should be spaced by a minimum of 2 weeks or in case of a shorter time, with negative urine culture between them * Women who use contraception to prevent pregnancy and who do not plan a pregnancy during the study period
Exclusion criteria
* Pregnant or breastfeeding women * Underlying chronic disease: diabetes mellitus, kidney failure, cancer, spinal cord injury, polycystic ovary * Women wih catheters in the urethra * Women who consume probiotics or foods, beverages or supplements containing extracts or parts of the genus Vaccinum sp, including other forms of V. macrocarpon (blueberry), V. myrtillus (European blueberry), V. angustifolium (wild or low buch blueberry), V. corymbosum (tall bch blueberry) or V. vitis-ideae (mountain blueberry) during the 2 weels prior to recruitment. * High consumption of fruits rich in phenolic compounds, with special reference, to berries * Women allergic to red fruits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Urninary Tract Infections (UTIs) | month 6 | Number of women who have recurrence of UTIs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time without UTI | month 6 | Time (in days) disease free until the next UTI |
| Total symptomatic UTIs number | month 6 | Number of symptomatic UTIs |
| Change in UTI symptomatology | baseline, month 6 | Change in the presence of UTI-related list of symptoms documented in CRF as "yes" or "no" |
| Change in Microbiota | baseline, month 6 | Change in Lactobacillus plantarum levels in the vaginal/perianal microbiota |
| Incidence of Treatment-Emergent Adverse Events | From baseline until month 6 | Assessed by the reporting of Adverse Events |
| Satisfaction with the product | Month 6 | Consumer's satisfaction with the product assessed through Likert scale (ranging from very unsatisfied to very satisfied) |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORAntonio Prieto González, MD
Hospital Universitario Virgen de la Arrixaca
Outcome results
None listed