Recurrent Urinary Tract InfectionPROBUTINCT05895578
Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
A study testing Probiotic in people with Recurrent Urinary Tract Infection, run by ProbiSearch SL at 3 sites in Spain.
Trial summary
Urinary tract infections (UTIs) are the most common bacterial infections in women. 50% of women experiencing at least one UTI in their lifetime with an annual prevalence of 0.5-0.7%. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 3 sitesSpain
- Study dates
- 21 Jun 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women with aged between 18 and 65 years old, diagnosed with recurrent UTI (defined as at least two episodes during the last six months or three during the last 12 months).
- Diagnosed, the last 7days, for a new UTI episode.
- Written informed consent signed.
Who cannot join
- Pregnant, breastfeeding or planning to become pregnant during the study.
- Congenital abnormalities of the urinary tract.
- Renal functional alterations, such as neurogenic bladder or vesicoureteral reflux.
- Relevant renal disorders, such as interstitial cystitis, renal lithiasis, renal failure, kidney transplantation, pyelonephritis, renal nephropathy, etc.
- Permanent catheter.
- Immunocompromised (eg: cancer and/or transplant, patients who are taking immunosuppressive drugs, patients with hereditary diseases that affect or may affect the immune system).
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- Type I diabetes.
- With a defect in the intestinal epithelium barrier (eg: chronic diarrhea, inflammatory bowel disease).
- Heart failure and cardiac medical history (eg, artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation).
- Under antibiotics prophylactic treatment without willingness to leave it at the time of inclusion.
- Probiotics supplementation during the previous 2 weeks.
- To have received Urovac, Uro-Vaxom or equivalent vaccine during the last year.
- Currently participating in another clinical trial.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital La Moraleja
Madrid
Hospital La Zarzuela
Madrid
Hospital San Francisco de Asís
Madrid
About this study
Official title: Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic on the Urinary Tract Microbiota in Women With Recurrent Urinary Tract Infections (rUTI).
Urinary tract infections (UTIs) are the most common bacterial infections in women. 50% of women experiencing at least one UTI in their lifetime with an annual prevalence of 0.5-0.7%.
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strains on the urinary tract microbiota in participants with recurrent urinary tract infection (rUTI).
The study duration will be 6 and a half months, including 6 months product intake. Participants will be randomly assigned to one of the three study groups: control group with placebo administration, probiotic administration group (1 dose) and probiotic administration group (2 doses).
- Conditions
- Recurrent Urinary Tract Infection
- Being tested
- Probiotic, Probiotic + placebo, Placebo
- 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.
ProbioticDietary supplement
1 capsule of probiotic (Lactobacillus CECT 9422 + Bifidobacterium CECT 30257) every 12 hours for 6-months.
Probiotic + placeboDietary supplement
1 capsule of probiotic + 1 capsule of placebo per day for 6-months.
PlaceboDietary supplement
1 capsule of placebo every 12 hours for 6-months.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | 2 Capsule daily containing approximately 1*10E9 colony forming unit (CFU) of Lactobacillus CECT 9422 +1*10E9 colony forming unit (CFU) of Bifidobacterium CECT 30257. Receives: Dietary Supplement: Probiotic |
| Probiotic + placebo | Active comparator | One capsule daily containing approximately 1*10E9 colony forming unit (CFU) of Lactobacillus CECT 9422 +1*10E9 colony forming unit (CFU) of Bifidobacterium CECT 30257 and 1 capsule of placebo supplement. Receives: Dietary Supplement: Probiotic + placebo |
| Placebo | Placebo comparator | Two capsules daily of Placebo supplement. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the number of participants with a positive urine culture
The number of participants with a positive urine culture will be compared between groups of treatment.
Measured: Before intervention
Evaluate the number of participants with a positive urine culture
The number of participants with a positive urine culture will be compared between groups of treatment.
Measured: After 3 months of intervention.
Evaluate the number of participants with a positive urine culture
The number of participants with a positive urine culture will be compared between groups of treatment.
Measured: After 6 months of intervention.
Evaluate the total bacterial count in urine samples.
The total bacterial count in urine samples will be compared between groups of treatment.
Measured: Before intervention
Evaluate the total bacterial count in urine samples.
The total bacterial count in urine samples will be compared between groups of treatment.
Measured: After 3 months of intervention
Evaluate the total bacterial count in urine samples.
The total bacterial count in urine samples will be compared between groups of treatment.
Measured: After 6 months of intervention
Secondary outcomes (33)
Number of UTI episodes
Measured: After 3 and 6 months of intervention.
Infection free participants (%)
Measured: After 6 months of intervention.
Elapsed time until the 1st episode of UTI.
Measured: After 6 months of intervention.
Elapsed time between the 1st and 2nd episode of UTI.
Measured: After 6 months of intervention.
Elapsed time between the 2nd and 3rd episode of UTI.
Measured: After 6 months of intervention.
Duration of UTI episodes.
Measured: After 6 months of intervention.
The number of participants which associate sexual activity with the UTI episodes
The number of participants which associate sexual activity with the apperance of an UTI episode will be counted and compared between groups.
Measured: After 6 months of intervention.
Number of present symptoms during new UTI episodes.
Measured: After 6 months of intervention.
Number of participants with dysuria.
Measured: After 6 months of intervention.
Duration of dysuria.
Measured: After 6 months of intervention.
Number of participants with pollakiuria
Measured: After 6 months of intervention.
Duration of pollakiuria
Measured: After 6 months of intervention.
Number of participants with urinary urgency.
Measured: After 6 months of intervention.
Duration of urinary urgency.
Measured: After 6 months of intervention.
Number of participants with tenesmus.
Measured: After 6 months of intervention.
Duration of tenesmus.
Measured: After 6 months of intervention.
Number of participants with hematuria.
Measured: After 6 months of intervention.
Duration of hematuria
Measured: After 6 months of intervention.
Number of participants with dyspareunia
Measured: After 6 months of intervention.
Duration of dyspareunia
Measured: After 6 months of intervention.
Number of participants with pelvic pain
Measured: After 6 months of intervention.
Duration of pelvic pain
Measured: After 6 months of intervention.
Number of participants with fever (Tª ≥ 38ºC).
Measured: After 6 months of intervention.
Duration of fever (Tª ≥ 38ºC).
Measured: After 6 months of intervention.
Number of participants with cloudy and smelly urine
Measured: After 6 months of intervention.
Duration of cloudy and smelly urine
Measured: After 6 months of intervention.
Number of antibiotics administered for the UTI episode.
Measured: After 6 months of intervention.
Duration of antibiotic treatment for the UTI episode.
Measured: After 6 months of intervention.
Number of antibiotic treatments administered during new UTI episodes.
Measured: After 6 months of intervention.
Duration of antibiotic treatments administered during new UTI episodes.
Measured: After 6 months of intervention.
Microbiome composition of stool samples determined by 16S sequencing.
The composition of fecal microbiome will be compared between treatments group and time
Measured: After 6 months of intervention.
Microbiota composition of urine samples determined by culture techniques.
The composition of urine microbiota will be compared between treatments group and time.
Measured: After 6 months of intervention.
Metabolomic profile of urine samples.
Measured: After 6 months of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start21 Jun 2023
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProbiSearch SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895578
- Sponsor's protocol ID
- UTI/23.01
- Acronym
- PROBUTI
- Status last verified
- Jul 2026
- First submitted
- 19 May 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic on the Urinary Tract Microbiota in Women With Recurrent Urinary Tract Infections (rUTI).
- ClinicalTrials.gov ID
- NCT05895578
- Acronym / sponsor ID
- PROBUTI / UTI/23.01
- Conditions
- Recurrent Urinary Tract Infection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- ProbiSearch SLIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Jun 2023 (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.
Urinary tract infections (UTIs) are the most common bacterial infections in women. 50% of women experiencing at least one UTI in their lifetime with an annual prevalence of 0.5-0.7%.
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strains on the urinary tract microbiota in participants with recurrent urinary tract infection (rUTI).
The study duration will be 6 and a half months, including 6 months product intake. Participants will be randomly assigned to one of the three study groups: control group with placebo administration, probiotic administration group (1 dose) and probiotic administration group (2 doses).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Probiotic2 Capsule daily containing approximately 1*10E9 colony forming unit (CFU) of Lactobacillus CECT 9422 +1*10E9 colony forming unit (CFU) of Bifidobacterium CECT 30257. |
| Probiotic + placebo | Active comparator | Dietary Supplement: Probiotic + placeboOne capsule daily containing approximately 1*10E9 colony forming unit (CFU) of Lactobacillus CECT 9422 +1*10E9 colony forming unit (CFU) of Bifidobacterium CECT 30257 and 1 capsule of placebo supplement. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTwo capsules daily of Placebo supplement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult women with aged between 18 and 65 years old, diagnosed with recurrent UTI (defined as at least two episodes during the last six months or three during the last 12 months).
- Diagnosed, the last 7days, for a new UTI episode.
- Written informed consent signed.
Key exclusion criteria (13 listed)
- Pregnant, breastfeeding or planning to become pregnant during the study.
- Congenital abnormalities of the urinary tract.
- Renal functional alterations, such as neurogenic bladder or vesicoureteral reflux.
- Relevant renal disorders, such as interstitial cystitis, renal lithiasis, renal failure, kidney transplantation, pyelonephritis, renal nephropathy, etc.
- Permanent catheter.
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 |
|---|---|---|
| Probiotic1 capsule of probiotic (Lactobacillus CECT 9422 + Bifidobacterium CECT 30257) every 12 hours for 6-months. | Dietary supplement | Probiotic |
| Probiotic + placebo1 capsule of probiotic + 1 capsule of placebo per day for 6-months. | Dietary supplement | Probiotic + placebo |
| Placebo1 capsule of placebo every 12 hours for 6-months. | Dietary supplement | Placebo |
Primary outcome
Evaluate the number of participants with a positive urine culture
Time frame: Before intervention
The number of participants with a positive urine culture will be compared between groups of treatment.
Evaluate the number of participants with a positive urine culture
Time frame: After 3 months of intervention.
The number of participants with a positive urine culture will be compared between groups of treatment.
Evaluate the number of participants with a positive urine culture
Time frame: After 6 months of intervention.
The number of participants with a positive urine culture will be compared between groups of treatment.
Evaluate the total bacterial count in urine samples.
Time frame: Before intervention
The total bacterial count in urine samples will be compared between groups of treatment.
Evaluate the total bacterial count in urine samples.
Time frame: After 3 months of intervention
The total bacterial count in urine samples will be compared between groups of treatment.
Evaluate the total bacterial count in urine samples.
Time frame: After 6 months of intervention
The total bacterial count in urine samples will be compared between groups of treatment.
33 secondary outcomes
Number of UTI episodes
Time frame: After 3 and 6 months of intervention.
Infection free participants (%)
Time frame: After 6 months of intervention.
Elapsed time until the 1st episode of UTI.
Time frame: After 6 months of intervention.
Elapsed time between the 1st and 2nd episode of UTI.
Time frame: After 6 months of intervention.
Elapsed time between the 2nd and 3rd episode of UTI.
Time frame: After 6 months of intervention.
Duration of UTI episodes.
Time frame: After 6 months of intervention.
The number of participants which associate sexual activity with the UTI episodes
Time frame: After 6 months of intervention.
Number of present symptoms during new UTI episodes.
Time frame: After 6 months of intervention.
Number of participants with dysuria.
Time frame: After 6 months of intervention.
Duration of dysuria.
Time frame: After 6 months of intervention.
Number of participants with pollakiuria
Time frame: After 6 months of intervention.
Duration of pollakiuria
Time frame: After 6 months of intervention.
Number of participants with urinary urgency.
Time frame: After 6 months of intervention.
Duration of urinary urgency.
Time frame: After 6 months of intervention.
Number of participants with tenesmus.
Time frame: After 6 months of intervention.
Duration of tenesmus.
Time frame: After 6 months of intervention.
Number of participants with hematuria.
Time frame: After 6 months of intervention.
Duration of hematuria
Time frame: After 6 months of intervention.
Number of participants with dyspareunia
Time frame: After 6 months of intervention.
Duration of dyspareunia
Time frame: After 6 months of intervention.
Number of participants with pelvic pain
Time frame: After 6 months of intervention.
Duration of pelvic pain
Time frame: After 6 months of intervention.
Number of participants with fever (Tª ≥ 38ºC).
Time frame: After 6 months of intervention.
Duration of fever (Tª ≥ 38ºC).
Time frame: After 6 months of intervention.
Number of participants with cloudy and smelly urine
Time frame: After 6 months of intervention.
Duration of cloudy and smelly urine
Time frame: After 6 months of intervention.
Number of antibiotics administered for the UTI episode.
Time frame: After 6 months of intervention.
Duration of antibiotic treatment for the UTI episode.
Time frame: After 6 months of intervention.
Number of antibiotic treatments administered during new UTI episodes.
Time frame: After 6 months of intervention.
Duration of antibiotic treatments administered during new UTI episodes.
Time frame: After 6 months of intervention.
Microbiome composition of stool samples determined by 16S sequencing.
Time frame: After 6 months of intervention.
Microbiota composition of urine samples determined by culture techniques.
Time frame: After 6 months of intervention.
Metabolomic profile of urine samples.
Time frame: After 6 months of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Recurrent Urinary Tract Infection, run by ProbiSearch SL at 3 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 3 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
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?
Evaluate the number of participants with a positive urine culture (time frame: Before intervention). The study lists 6 primary outcomes in all. 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 14 Aug 2026.