Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.

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).

Inclusion Criteria:

• 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.

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.