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

NCT07884929 | Active Not Recruiting DMC

• 1 other identifier: BIO-RUTI-26
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Urinary Tract Infections

Keywords

Recurrent UTI; Food Supplement; Probiotics

Outcome Measures

Primary Outcomes (1)

• Time to first recurrence of a symptomatic uncomplicated urinary tract infection (UTI).

  The efficacy of the food supplement containing L. plantarum PBS067, L. rhamnosus LRH020, and B. animalis subsp. lactis BL050 will be evaluated based on the time to first recurrence of a symptomatic uncomplicated UTI during the 24-week observation period. A UTI recurrence will be considered confirmed in the presence of urinary tract infection symptoms (ACSS "Typical Symptoms" score \>6) together with microbiological and/or rapid diagnostic evidence, including a urine culture showing \>10⁵ CFU/mL in a midstream urine sample and/or a positive rapid test for urinary leukocytes and pH. During scheduled visits, participants reporting symptoms suggestive of acute UTI will undergo diagnostic confirmation. In the absence of symptoms, the ACSS questionnaire and a rapid test for urinary leukocytes will be performed; urine culture will be performed when indicated by the rapid test result.

  T0 - baseline; T1 - after 28 days of treatment; T2 - after 140 days, at the end of the maintenance phase; T3 - after 168 days, at the end of the 28-day follow-up period

Secondary Outcomes (8)

• Cumulative incidence of UTI recurrence

  T3 - after 168 days, at the end of follow-up period

• Number of antibiotic treatment courses for UTIs

  T1 - after 28 days of treatment, T2 - after 140 days after treatment initiation, T3 - after 168 days at the end of follow-up, and at additional visits in the event of symptomatic UTIs

• UTI symptom severity, impact on daily activities, and quality of life

  T0 - baseline, T1 - after 28 days of treatment, T2 - after 140 days of the treatment start, T3 - after 168 days at the end of follow-up, and at additional visits in the event of symptomatic UTIs

• Urinary leukocyte rapid test

  T0 - baseline, and at additional visits in the event of symptomatic UTIs

• Urine pH

  T0 - baseline, and at additional visits in the event of symptomatic UTIs

Study Arms (2)

Group treated with food supplement

EXPERIMENTAL

35 healthy women with a history of recurrent uncomplicated urinary tract infections will receive the active food supplement containing L. plantarum PBS067, L. rhamnosus LRH020, and B. animalis subsp. lactis BL050. Participants will receive one capsule daily for 28 consecutive days (intensive phase), followed by one capsule daily for 7 consecutive days per month, with a 3-week treatment-free interval between monthly administrations, for approximately 4 months (maintenance phase; 28 non-consecutive treatment days in total). This will be followed by a 28-day treatment-free observation period.

Dietary Supplement: Dietary Supplement containing probiotics

Placebo

PLACEBO COMPARATOR

35 healthy women with a history of recurrent uncomplicated urinary tract infections will receive a placebo capsule identical in appearance to the active product and administered according to the same schedule. Participants will receive one capsule daily for 28 consecutive days (intensive phase), followed by one capsule daily for 7 consecutive days per month, with a 3-week treatment-free interval between monthly administrations, for approximately 4 months (maintenance phase; 28 non-consecutive treatment days in total). This will be followed by a 28-day treatment-free observation period.

Dietary Supplement: Placebo

Interventions

Dietary Supplement containing probiotics DIETARY_SUPPLEMENT

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

Group treated with food supplement

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synbalance S.r.l.: lead

Study Sites (1)

COMEGEN Soc. Coop. Sociale

Naples, Campania, 80126, Italy

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-center, randomized, controlled, double-blind, two-arm parallel clinical trial, placebo-controlled

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 21, 2026
• Study Start: October 14, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)