An interventional study of Dietary Supplement containing probiotics and Placebo in Recurrent Urinary Tract Infections, sponsored by Synbalance S.r.l.. Active, not recruiting at 1 site in Italy. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Synbalance S.r.l. · Not applicable, Interventional, and Prevention
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.
Recurrent urinary tract infections (UTIs) affect a large proportion of otherwise healthy women, with an estimated 20-30% of women who experience a first episode going on to have further episodes. Standard management relies heavily on antibiotics, and repeated antibiotic courses are associated with an increased risk of antimicrobial resistance, alteration of the intestinal and urogenital microbiota, and higher healthcare costs. There is growing interest in non-antibiotic, microbiota-based strategies for the prevention of recurrent UTIs, based on the concept of a functional gut-bladder axis, whereby modulation of the intestinal microbiota can influence colonization resistance and inflammatory status at the level of the urogenital tract.
The investigational product is a food supplement containing a pool of three probiotic strains: L. plantarum PBS067 (DSM 24937), L. rhamnosus LRH020 (DSM 25568), and B. animalis subsp. lactis BL050 (DSM 25566). These strains have previously demonstrated favorable effects on the vaginal microbiota and inflammatory profile, supporting their evaluation as a microbiota-based strategy for recurrent UTI prevention. This is a single-center, randomized, double-blind, placebo-controlled, two-arm parallel-group study. Seventy eligible women will be randomized in a 1:1 ratio to receive either the active food supplement or a matching placebo. Randomization and blinding procedures ensure that neither participants nor site personnel are aware of treatment allocation for the duration of the study.
The treatment regimen consists of three phases: an intensive phase (one capsule per day for 28 consecutive days), a maintenance phase (one capsule per day for 7 consecutive days per month, after a three-week interruption each month, repeated for approximately 4 months, for a total of 28 non-consecutive treatment days), and a treatment-free follow-up phase of 28 days. The overall observation period per participant is approximately 24 weeks (168 days).
Assessments are performed at baseline, day 28, day 140, and day 168, with additional visits in case of suspected urinary tract infection recurrence. Urinary symptoms are assessed using the Acute Cystitis Symptom Score (ACSS), while urine testing and urine culture are used for diagnostic confirmation when clinically indicated. Quality of life is assessed using the SF-12 questionnaire. Stool samples are collected for strain-specific detection of probiotic strains in a subgroup of participants and for characterization of gut microbiota composition.
The study is sponsored by the manufacturer of the investigational food supplement and is being conducted in accordance with Italian Ministry of Health guidance on clinical studies evaluating the physiological effects of food products, which requires that any such study target the maintenance of a homeostatic function of the organism (or the reduction of a disease risk factor) rather than a therapeutic claim.
779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.
This study's planned enrollment of 70 is below the median of 130 across 544 interventional studies indexed under Urinary Tract Infections.
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Female participants meeting all of the following criteria will be eligible for participation:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
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
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
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
Matching placebo identical in appearance and administration schedule to the active product.
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.
Time frame: 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
Cumulative incidence of UTI recurrence
Cumulative incidence of symptomatic uncomplicated UTI recurrence from baseline through the end of the follow-up period, comparing the probiotic treatment group with the placebo control group.
Time frame: T3 - after 168 days, at the end of follow-up period
Number of antibiotic treatment courses for UTIs
Number of antibiotic treatment courses required for the treatment of symptomatic uncomplicated UTIs during the study period. Data will be collected by the investigator and recorded in the CRF
Time frame: 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
Assessment of UTI symptom severity, impact on daily activities, and quality of life using the Acute Cystitis Symptom Score (ACSS), including the follow-up module (Part B), in the event of a UTI recurrence
Time frame: 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
Urinary leukocytes will be assessed using a rapid urine dipstick test on a midstream urine sample to support the assessment of the presence or absence of acute UTI
Time frame: T0 - baseline, and at additional visits in the event of symptomatic UTIs
Urine pH
Urine pH will be assessed using a rapid urine dipstick test on a midstream urine sample
Time frame: T0 - baseline, and at additional visits in the event of symptomatic UTIs
Detection and persistence of probiotic strains in stool samples
Presence and persistence of L. plantarum PBS067, L. rhamnosus LRH020 and B. animalis subsp. lactis BL050 will be evaluated using strain-specific qPCR assays in a subgroup of 30 participants (15 per treatment arm).
Time frame: T0 - baseline, T2 - after 140 days, at the end of treatment
Evaluation of fecal microbiota modulation
Fecal microbiota composition will be assessed in stool samples collected from all subjects enrolled in the study (35 subjects per treatment group), including subjects treated with the probiotic product under investigation and subjects receiving placebo. The microbiota profiles will be compared between the two treatment groups using 16S rRNA gene sequencing (16S metagenomics)
Time frame: T0 - baseline, T2 - after 140 days, at the end of treatment
Evaluation of perceived quality of life over the last 4 weeks.
Perceived quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12) questionnaire. The SF-12 score will be assessed at baseline and at the end of the treatment period.
Time frame: T0 (baseline), T2 - after 140 days, at the end of treatment
Plan to share: No
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