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RECRUITING
NCT05895578
NA

Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.

Sponsor: ProbiSearch SL

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Probiotic

1 capsule of probiotic (Lactobacillus CECT 9422 + Bifidobacterium CECT 30257) every 12 hours for 6-months.

DIETARY_SUPPLEMENT

Probiotic + placebo

1 capsule of probiotic + 1 capsule of placebo per day for 6-months.

DIETARY_SUPPLEMENT

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