Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
NCT ID: NCT05895578
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2023-06-21
2026-03-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Probiotic
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.
Probiotic
1 capsule of probiotic (Lactobacillus CECT 9422 + Bifidobacterium CECT 30257) every 12 hours for 6-months.
Probiotic + placebo
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.
Probiotic + placebo
1 capsule of probiotic + 1 capsule of placebo per day for 6-months.
Placebo
Two capsules daily of Placebo supplement.
Placebo
1 capsule of placebo every 12 hours for 6-months.
Interventions
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Probiotic
1 capsule of probiotic (Lactobacillus CECT 9422 + Bifidobacterium CECT 30257) every 12 hours for 6-months.
Probiotic + placebo
1 capsule of probiotic + 1 capsule of placebo per day for 6-months.
Placebo
1 capsule of placebo every 12 hours for 6-months.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed, the last 7days, for a new UTI episode.
* Written informed consent signed.
Exclusion Criteria
* 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).
* 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.
18 Years
55 Years
FEMALE
No
Sponsors
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ProbiSearch SL
INDUSTRY
Responsible Party
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Locations
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Hospital La Moraleja
Madrid, , Spain
Hospital La Zarzuela
Madrid, , Spain
Hospital San Francisco de Asís
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Miguel Ángel Rodriguez, MD, PhD
Role: primary
Elisa Diaz de Terán, MD
Role: primary
José Ángel Espinosa, MD
Role: primary
Other Identifiers
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UTI/23.01
Identifier Type: -
Identifier Source: org_study_id
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