Effect of Probiotics on Recurrent Urinary Tract Infections (CYSCARE)

AB Biotics

Status: Terminated

Conditions: Urinary Tract Infections

Treatments: Dietary Supplement: Food supplement; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06192966

AB-CYSCARE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Food supplement

Placebo

Placebo Comparator group

Description:

Placebo composed of maltodextrin

Treatment:

Dietary Supplement: Placebo