NCT06192966

Effect of Probiotics on Recurrent Urinary Tract Infections

Efficacy of a Food Supplement for the Treament of Recurrent Urinary Tract Infections

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: AB Biotics, SA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Food supplement	Probiotic formulation containing Lactobacillus plantarum, cranberry and vitamine C for 6 months 1 capsule/day
DIETARY_SUPPLEMENT	Placebo	Placebo composed of maltodextrin for 6 months 1 capsule/day

Timeline

• Start date: 2018-01-01
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2024-01-05
• Last updated: 2026-01-29

Locations

4 sites across 1 country: Spain