Probiotic treatment for recurrent urinary tract infections

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).

This study is testing if taking probiotics can help women aged 18 to 55 with recurrent urinary tract infections by changing their urinary bacteria and reducing the number of infections they get.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 55 Years
• Sex: Female
• Sponsor: ProbiSearch SL (Industry-sponsored)
• Locations: 3 sites (Madrid and 2 other locations)
• Trial ID: NCT05895578 on ClinicalTrials.gov

What this trial studies

This interventional study investigates the impact of probiotic strains on the urinary tract microbiota in women suffering from recurrent urinary tract infections (rUTIs). Participants aged 18 to 55 will be randomly assigned to receive either a placebo, a single dose of probiotics, or two doses of probiotics over a six-month period. The study aims to determine whether probiotics can effectively alter the urinary microbiota and reduce the incidence of UTIs. The trial will last for a total of six and a half months, including the treatment phase.

Who should consider this trial

Good fit: Ideal candidates are adult women aged 18 to 55 with a history of recurrent UTIs.

Not a fit: Patients who are menopausal, pregnant, immunocompromised, or have significant renal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel and effective treatment option for women suffering from recurrent urinary tract infections.

How similar studies have performed: Other studies have shown promising results with probiotics in managing urinary tract infections, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Adult women with aged between 18 and 55 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:

* Menopausal
* 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.

Where this trial is running

Madrid and 2 other locations

• Hospital La Moraleja — Madrid, Spain (Recruiting)
• Hospital La Zarzuela — Madrid, Spain (Recruiting)
• Hospital San Francisco de Asís — Madrid, Spain (Recruiting)

Study contacts

• Study coordinator: Susana Manzano Jiménez, PhD

Conditions Recurrent Urinary Tract Infection