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

Last updated: February 19, 2025
Sponsor: ProbiSearch SL
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Tract Infections

Treatment

Probiotic + placebo

Probiotic

Placebo

Clinical Study ID

NCT05895578
UTI/23.01
  • Ages 18-55
  • Female

Study 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%.

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).

Eligibility Criteria

Inclusion

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 thelast 12 months).

  • Diagnosed, the last 7days, for a new UTI episode.

  • Written informed consent signed.

Exclusion

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, renalfailure, kidney transplantation, pyelonephritis, renal nephropathy, etc.

  • Permanent catheter.

  • Immunocompromised (eg: cancer and/or transplant, patients who are takingimmunosuppressive drugs, patients with hereditary diseases that affect or may affectthe 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, medicalhistory of infective endocarditis, rheumatic fever, or cardiac malformation).

  • Under antibiotics prophylactic treatment without willingness to leave it at the timeof 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.

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Probiotic + placebo
Phase:
Study Start date:
June 21, 2023
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Hospital La Moraleja

    Madrid,
    Spain

    Active - Recruiting

  • Hospital La Zarzuela

    Madrid,
    Spain

    Active - Recruiting

  • Hospital San Francisco de Asís

    Madrid,
    Spain

    Active - Recruiting

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