NCT05895578

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

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).

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: ProbiSearch SL · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Recurrent Urinary Tract Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-21
• Primary completion: 2026-09-01
• Completion: 2026-11-01
• First posted: 2023-06-08
• Last updated: 2026-04-13

Locations

3 sites across 1 country: Spain