NCT06192966

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

4.2 years

First QC Date

December 21, 2023

Last Update Submit

January 28, 2026

Conditions

Urinary Tract Infections

Keywords

ProbioticsWomen healthMicrobiota

Outcome Measures

Primary Outcomes (1)

  • Recurrence of Urninary Tract Infections (UTIs)

    Number of women who have recurrence of UTIs

    month 6

Secondary Outcomes (6)

  • Time without UTI

    month 6

  • Total symptomatic UTIs number

    month 6

  • Change in UTI symptomatology

    baseline, month 6

  • Change in Microbiota

    baseline, month 6

  • Incidence of Treatment-Emergent Adverse Events

    From baseline until month 6

  • +1 more secondary outcomes

Study Arms (2)

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

Placebo

PLACEBO COMPARATOR

Placebo composed of maltodextrin

Dietary Supplement: Placebo

Interventions

Food supplementDIETARY_SUPPLEMENT

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

Experimental
PlaceboDIETARY_SUPPLEMENT

Placebo composed of maltodextrin for 6 months 1 capsule/day

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fundació Puigvert

Barcelona, Barcelona, 08025, Spain

Location

Hospital Universitario de Caceres

Cáceres, Cáceres, 1004, Spain

Location

Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario Virgen de Arrixaca

Murcia, Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Antonio Prieto González, MD

    Hospital Universitario Virgen de la Arrixaca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Probiotic and placebo products will be provided in identical packaging
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Double-blind, randomized, placebo controlled trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2023

First Posted

January 5, 2024

Study Start

January 1, 2018

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(4)