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

Launched by PROBISEARCH SL · May 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effect of probiotics on women who have recurrent urinary tract infections (UTIs). The goal is to see if taking specific probiotic strains can help restore a healthy balance of bacteria in the urinary tract and potentially reduce the frequency of UTIs. The study will last for about six and a half months, during which participants will take either a probiotic or a placebo (a non-active pill) for six months.

To participate, women must be between 18 and 55 years old and have had at least two UTIs in the past six months or three in the past year. They should also have been diagnosed with a new UTI within the last week. However, women who are pregnant, breastfeeding, or have certain medical conditions like severe kidney issues or weakened immune systems are not eligible. Participants will be randomly assigned to one of three groups: one receiving a placebo, one receiving one dose of the probiotic, and another receiving two doses. Throughout the study, participants will be monitored for their health and any changes in their urinary tract health.

Gender

FEMALE

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.