Trial · NCT07884929
Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
NCT07884929, Not applicable, Active not recruiting, Synbalance S.r.l.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis). Trials, record NCT07884929. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07884929
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
- NCT number
- NCT07884929
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 70 participants, estimated
- Lead sponsor
- Synbalance S.r.l.
- Conditions
- Recurrent Urinary Tract Infections
- Interventions
- Dietary Supplement containing probiotics, Placebo
- First posted
- 2026-10-21
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to first recurrence of a symptomatic uncomplicated urinary tract infection (UTI). | 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 | 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. |
| Secondary | Cumulative incidence of UTI recurrence | T3 - after 168 days, at the end of follow-up period | 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. |
| Secondary | 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 | 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 |
| Secondary | 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 | 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. The questionnaire is divided into specific domains, with most items scored on a 4-point Likert scale ranging from 0 (no symptoms/no impact) to 3 (severe symptoms/high impact). Typical Symptoms (score 0-18). Differential Diagnosis Symptoms (score 0-12). Quality of Life (score 0-9). A higher score in the Typical Symptoms and QoL domains indicates greater disease severity and functional impairment. |
| Secondary | Urinary leukocyte rapid test | T0 - baseline, and at additional visits in the event of symptomatic UTIs | 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 |
| Secondary | Urine pH | T0 - baseline, and at additional visits in the event of symptomatic UTIs | Urine pH will be assessed using a rapid urine dipstick test on a midstream urine sample |
| Secondary | Detection and persistence of probiotic strains in stool samples | T0 - baseline, T2 - after 140 days, at the end of treatment | 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). |
| Secondary | Evaluation of fecal microbiota modulation | T0 - baseline, T2 - after 140 days, at the end of treatment | 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) |
| Secondary | Evaluation of perceived quality of life over the last 4 weeks. | T0 (baseline), T2 - after 140 days, at the end of treatment | 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. The survey consists of 12 questions covering eight health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These items are aggregated and weighted to calculate two primary summary scores. Physical Component Summary (PCS): Evaluates overall physical health and limitations. Mental Component Summary (MCS): Evaluates overall psychological distress and well-being. Minimum Score: 0 (represents the lowest possible level of health and maximum severe disability). Maximum score: 100 (represents the highest possible level of health and zero disability). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07884929
GET https://conductscience.org/api/trials/v1/NCT07884929/registered