Effect of Probiotics on Recurrent Urinary Tract Infections

Not Applicable

Terminated

• Conditions: Urinary Tract Infections
• Interventions: Dietary Supplement: Food supplement; Dietary Supplement: Placebo

• Registration Number: NCT06192966
• Lead Sponsor: AB Biotics, SA

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2023-12-21
• Status Verified: 2024-01
• Study First Posted: 2024-01-05
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 106

Inclusion Criteria

• Women over 18 years of age.
• Women who have had at least one episode of UTI in the past 2 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
• BMI ≥ 40 Kg/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Food supplement	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.
Placebo	Placebo	Placebo composed of maltodextrin

Primary Outcome Measures

Name	Time	Method
Recurrence of Urninary Tract Infections (UTIs)	month 6	Number of women who have recurrence of UTIs

Secondary Outcome Measures

Name	Time	Method
Total symptomatic UTIs number	month 6	Number of symptomatic UTIs
Change in UTI symptomatology	baseline, month 6	Change in the presence of UTI-related list of symptoms documented in CRF as "yes" or "no"
Incidence of Treatment-Emergent Adverse Events	From baseline until month 6	Assessed by the reporting of Adverse Events
Change in Microbiota	baseline, month 6	Change in Lactobacillus plantarum levels in the vaginal/perianal microbiota
Time without UTI	month 6	Time (in days) disease free until the next UTI
Satisfaction with the product	Month 6	Consumer's satisfaction with the product assessed through Likert scale (ranging from very unsatisfied to very satisfied)

Trial Locations

Locations (4)

Hospital Universitario de Caceres; 🇪🇸 Caceres, Cáceres, Spain

Hospital Universitario Virgen de Arrixaca; 🇪🇸 Murcia, Spain

Fundació Puigvert; 🇪🇸 Barcelona, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain