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ACTIVE NOT RECRUITING

NCT07884929

Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)

Sponsor: Synbalance S.r.l.

View on ClinicalTrials.gov

Summary

This randomized, double-blind, placebo-controlled trial will evaluate the efficacy of a probiotic food supplement containing Lactiplantibacillus plantarum PBS067, Lacticaseibacillus rhamnosus LRH020, and Bifidobacterium animalis subsp. lactis BL050 in women with recurrent uncomplicated urinary tract infections (UTIs). Seventy healthy non-menopausal women aged 18 to 50 years with a history of recurrent uncomplicated acute cystitis will be randomized 1:1 to receive either the probiotic supplement or placebo. Participants will undergo a 28-day intensive treatment phase followed by a maintenance phase consisting of 7 treatment days per month for approximately 4 months and a 28-day treatment-free follow-up period. The primary objective is to evaluate the effect of the probiotic supplement on time to first recurrence of symptomatic uncomplicated UTI over a 24-week observation period. Secondary objectives include assessment of cumulative recurrence incidence, antibiotic use, urinary symptom severity, quality of life, fecal persistence of the probiotic strains, and changes in gut microbiota composition.

Official title: Efficacy of a Probiotic Food Supplement (L. Plantarum, L. Rhamnosus, B. Lactis) for Reducing Recurrent Urinary Tract Infections in Healthy Women: A Single-center, Randomized, Double-blind, Controlled Trial.

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-14

Completion Date

2027-04-30

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Recurrent Urinary Tract Infections

Interventions

DIETARY_SUPPLEMENT

Dietary Supplement containing probiotics

One capsule per day containing the probiotic formulation (L. plantarum PBS067, L. rhamnosus LRH020, B. animalis subsp. lactis BL050) administered according to the study schedule

DIETARY_SUPPLEMENT

Placebo

Matching placebo identical in appearance and administration schedule to the active product.

Inclusion Criteria: Female participants meeting all of the following criteria will be eligible for participation: * Aged 18 to 50 years; * Not postmenopausal; * Able to understand and sign the informed consent form; * Able to understand and comply with the study requirements; * Negative HIV test; * Negative pregnancy test; * History of at least 2 episodes of uncomplicated acute cystitis within the 6 months prior to the baseline visit (T0), confirmed by urinalysis and/or previous urine culture with antimicrobial susceptibility testing; * No signs or symptoms of acute cystitis (e.g., dysuria, increased urinary frequency, or urgency) at the baseline visit (T0); * Negative rapid urine leukocyte test at baseline; * Urinary bacterial count \<10⁵ CFU/mL in a midstream urine sample at baseline; * Not currently receiving medications; * Not receiving antibiotic treatment or supplements for the prevention or management of recurrent urinary tract infections. Exclusion Criteria: Participants meeting any of the following criteria will be excluded: * Postmenopausal women; * Pregnancy, suspected pregnancy, or intention to become pregnant during the study period; * Unwillingness or inability to comply with study requirements; * Inability to attend the study site within the scheduled timeframes; * Predisposing factors or conditions associated with complicated urinary tract infections, including kidney disease, kidney stones, polycystic kidney disease, urinary tract abnormalities or previous urinary tract surgery, urinary catheterization, uncontrolled diabetes mellitus, spinal cord injury, neoplasms, immunosuppressive conditions, or signs of systemic infection or tissue invasion; * Signs or symptoms suggestive of complicated urinary tract infection or pyelonephritis (e.g., fever \>38°C, flank or back pain, or chills) within 14 days prior to the baseline visit, or unresolved previous urinary tract infection; * Vulvovaginitis at screening; * HIV infection or acquired immunodeficiency; * Severe visual or hearing impairment that may interfere with study participation; * Known allergy or hypersensitivity to any ingredient of the investigational product or placebo; * Alcohol, recreational drug, nicotine, caffeine, or theine abuse; * Use of antibacterial products that, in the investigator's opinion, may interfere with the study results; * Use of concomitant treatments, including food supplements, probiotics, or herbal products, administered systemically or topically, that may interfere with the study objectives, except for treatments prescribed by the investigator for the management of an acute UTI during the study; * Any past or concomitant medical condition, including diabetes, kidney disease, Crohn's disease, ulcerative colitis, or other conditions that, in the investigator's opinion may interfere with the study results.

Locations (1)

COMEGEN Soc. Coop. Sociale

Naples, Campania, Italy