Urinary Tract InfectionsCYSCARENCT06192966
Effect of Probiotics on Recurrent Urinary Tract Infections
A study testing Food supplement in people with Urinary Tract Infections, run by AB Biotics, SA at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Food supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 4 sitesSpain
- Study dates
- 1 Jan 2018to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Fundació Puigvert
Barcelona, Barcelona, 08025
Hospital Universitario de Caceres
Cáceres, Cáceres, 1004
Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital Universitario Virgen de Arrixaca
Murcia, Murcia, 30120
About this study
Official title: Efficacy of a Food Supplement for the Treament of Recurrent Urinary Tract Infections
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.
Read the detailed description
Double-blind, randomized, placebo-controlled clinical trial to determine the effect of two probiotic strains of Lactobacillus plantarum on recurrent urinary tract infections in women. Women are randomized 1:1 to one of the following study groups: one group will receive a capsule/day of the mixture of Lactobacillus plantarum in combination with cranberry, and vitamine C; and the other group will receive a capsule of placebo for 6 months. Main study outcome is the number of women who have recurrence of UTIs during th estudy compared to the placebo group. Secondary outcomes comprise the duration of disease free period, duration and severity of symptomatology, the number of symptomatic UTIs during the study, variation of Lactobacillus plantarum levels in the vaginal/perianal microbiota, product tolerability, safety and consumer's satisfaction with the product.
- Conditions
- Urinary Tract Infections
- Being tested
- Food supplement, Placebo
- Keywords
- Probiotics, Women health, Microbiota
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplementDietary supplement
Probiotic formulation containing Lactobacillus plantarum, cranberry and vitamine C for 6 months 1 capsule/day
PlaceboDietary supplement
Placebo composed of maltodextrin for 6 months 1 capsule/day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Food supplement |
| Placebo | Placebo comparator | Placebo composed of maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Urninary Tract Infections (UTIs)
Number of women who have recurrence of UTIs
Measured: month 6
Secondary outcomes (6)
Time without UTI
Time (in days) disease free until the next UTI
Measured: month 6
Total symptomatic UTIs number
Number of symptomatic UTIs
Measured: month 6
Change in UTI symptomatology
Change in the presence of UTI-related list of symptoms documented in CRF as "yes" or "no"
Measured: baseline, month 6
Change in Microbiota
Change in Lactobacillus plantarum levels in the vaginal/perianal microbiota
Measured: baseline, month 6
Incidence of Treatment-Emergent Adverse Events
Assessed by the reporting of Adverse Events
Measured: From baseline until month 6
Satisfaction with the product
Consumer's satisfaction with the product assessed through Likert scale (ranging from very unsatisfied to very satisfied)
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jan 2018
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Why it stopped: Lack of participants meeting selection criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, placebo controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Prieto González, MD, Principal investigator, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192966
- Sponsor's protocol ID
- AB-CYSCARE
- Acronym
- CYSCARE
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2023
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Food Supplement for the Treament of Recurrent Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT06192966
- Acronym / sponsor ID
- CYSCARE / AB-CYSCARE
- Conditions
- Urinary Tract Infections
- Keywords
- Probiotics, Women health, Microbiota
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participants meeting selection criteria
- Enrolment
- 106 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Double-blind, randomized, placebo-controlled clinical trial to determine the effect of two probiotic strains of Lactobacillus plantarum on recurrent urinary tract infections in women. Women are randomized 1:1 to one of the following study groups: one group will receive a capsule/day of the mixture of Lactobacillus plantarum in combination with cranberry, and vitamine C; and the other group will receive a capsule of placebo for 6 months. Main study outcome is the number of women who have recurrence of UTIs during th estudy compared to the placebo group. Secondary outcomes comprise the duration of disease free period, duration and severity of symptomatology, the number of symptomatic UTIs during the study, variation of Lactobacillus plantarum levels in the vaginal/perianal microbiota, product tolerability, safety and consumer's satisfaction with the product.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Food supplementProbiotic 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo composed of maltodextrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food supplementProbiotic formulation containing Lactobacillus plantarum, cranberry and vitamine C for 6 months 1 capsule/day | Dietary supplement | Experimental |
| PlaceboPlacebo composed of maltodextrin for 6 months 1 capsule/day | Dietary supplement | Placebo |
Primary outcome
Recurrence of Urninary Tract Infections (UTIs)
Time frame: month 6
Number of women who have recurrence of UTIs
6 secondary outcomes
Time without UTI
Time frame: month 6
Total symptomatic UTIs number
Time frame: month 6
Change in UTI symptomatology
Time frame: baseline, month 6
Change in Microbiota
Time frame: baseline, month 6
Incidence of Treatment-Emergent Adverse Events
Time frame: From baseline until month 6
Satisfaction with the product
Time frame: Month 6
Results and safety
The study was stopped early (reason given: Lack of participants meeting selection criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Prieto González, MD principal investigator
Hospital Universitario Virgen de la Arrixaca
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food supplement in people with Urinary Tract Infections, run by AB Biotics, SA at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of participants meeting selection criteria). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Urninary Tract Infections (UTIs) (time frame: month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.