Effect of Probiotics on Recurrent Urinary Tract Infections (CYSCARE)

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

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.

Study Overview

• Status: Terminated
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Dietary supplement: Food supplement; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08025
      • Fundació Puigvert
  • Cáceres
    • Cáceres, Cáceres, Spain, 1004
      • Hospital Universitario de Caceres
  • Madrid
    • Madrid, Madrid, Spain, 28040
      • Fundación Jiménez Díaz
  • Murcia
    • Murcia, Murcia, Spain, 30120
      • Hospital Universitario Virgen de Arrixaca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Food supplement; Probiotic formulation containing Lactobacillus plantarum, cranberry and vitamine C for 6 months 1 capsule/day
Placebo Comparator: Placebo; Placebo composed of maltodextrin	Dietary supplement: Placebo; Placebo composed of maltodextrin for 6 months 1 capsule/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of Urninary Tract Infections (UTIs)	Number of women who have recurrence of UTIs	month 6

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AB Biotics, SA
• Investigators: Principal Investigator: Antonio Prieto González, MD, Hospital Universitario Virgen de La Arrixaca

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Microbiota; Probiotics; Women health
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Urinary Tract Infections; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Supplements
• Other Study ID Numbers: AB-CYSCARE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No