Status:
TERMINATED
Effect of Probiotics on Recurrent Urinary Tract Infections
Lead Sponsor:
AB Biotics, SA
Conditions:
Urinary Tract Infections
Eligibility:
FEMALE
18+ years
Phase:
NA
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/peri...
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 random...
Eligibility Criteria
Inclusion
- Women over 18 years of age.
- Women who have had at least one episode of UTI in the past 2 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
- 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
- BMI ≥ 40 Kg/m2
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06192966
Start Date
January 1 2018
End Date
March 31 2022
Last Update
January 8 2024
Active Locations (4)
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1
Hospital Universitario de Caceres
Cáceres, Cáceres, Spain, 1004
2
Fundació Puigvert
Barcelona, Spain, 08025
3
Fundación Jiménez Díaz
Madrid, Spain, 28040
4
Hospital Universitario Virgen de Arrixaca
Murcia, Spain, 30120