Effect of Probiotics on Recurrent Urinary Tract Infections

NCT ID: NCT06192966

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2022-03-31

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/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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental

Probiotic formulation comprising Lactobacillus plantarum CECT8675 and CECT8677 in combination with cranberry, and vitamine C in a capsule format. Probiotic strains have Qualified Presumption of Safety (QPS) sttus by European Food Safety Authority.

Group Type: EXPERIMENTAL

Food supplement

Intervention Type: DIETARY_SUPPLEMENT

Probiotic formulation containing Lactobacillus plantarum, cranberry and vitamine C for 6 months 1 capsule/day

Placebo

Placebo composed of maltodextrin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo composed of maltodextrin for 6 months 1 capsule/day

Interventions

Food supplement

Probiotic formulation containing Lactobacillus plantarum, cranberry and vitamine C for 6 months 1 capsule/day

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo composed of maltodextrin for 6 months 1 capsule/day

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Women over 18 years of age.
• Women who have had at least one episode of UTI in the past 4 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

AB Biotics, SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Prieto González, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen de la Arrixaca

Locations

Fundació Puigvert

Barcelona, Barcelona, Spain

Hospital Universitario de Caceres

Cáceres, Cáceres, Spain

Fundación Jiménez Díaz

Madrid, Madrid, Spain

Hospital Universitario Virgen de Arrixaca

Murcia, Murcia, Spain

Countries

Spain

Other Identifiers

AB-CYSCARE

Identifier Type: -

Identifier Source: org_study_id