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Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
Sponsor: ProbiSearch SL
Summary
Urinary tract infections (UTIs) are the most common bacterial infections in women. 50% of women experiencing at least one UTI in their lifetime with an annual prevalence of 0.5-0.7%. An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strains on the urinary tract microbiota in participants with recurrent urinary tract infection (rUTI). The study duration will be 6 and a half months, including 6 months product intake. Participants will be randomly assigned to one of the three study groups: control group with placebo administration, probiotic administration group (1 dose) and probiotic administration group (2 doses).
Official title: Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic on the Urinary Tract Microbiota in Women With Recurrent Urinary Tract Infections (rUTI).
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2023-06-21
Completion Date
2026-11
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Probiotic
1 capsule of probiotic (Lactobacillus CECT 9422 + Bifidobacterium CECT 30257) every 12 hours for 6-months.
Probiotic + placebo
1 capsule of probiotic + 1 capsule of placebo per day for 6-months.
Placebo
1 capsule of placebo every 12 hours for 6-months.
Locations (3)
Hospital La Moraleja
Madrid, Spain
Hospital La Zarzuela
Madrid, Spain
Hospital San Francisco de Asís
Madrid, Spain