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NCT Number: NCT05895578

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital La Moraleja, Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement

1 capsule of probiotic (Lactobacillus CECT 9422 + Bifidobacterium CECT 30257) every 12 hours for 6-months.

Probiotic + placebo

Dietary Supplement

1 capsule of probiotic + 1 capsule of placebo per day for 6-months.

Placebo

Dietary Supplement

1 capsule of placebo every 12 hours for 6-months.

Primary outcomes

  1. Evaluate the number of participants with a positive urine culture

    Time frame: Before intervention

    The number of participants with a positive urine culture will be compared between groups of treatment.

  2. Evaluate the number of participants with a positive urine culture

    Time frame: After 3 months of intervention.

    The number of participants with a positive urine culture will be compared between groups of treatment.

  3. Evaluate the number of participants with a positive urine culture

    Time frame: After 6 months of intervention.

    The number of participants with a positive urine culture will be compared between groups of treatment.

  4. Evaluate the total bacterial count in urine samples.

    Time frame: Before intervention

    The total bacterial count in urine samples will be compared between groups of treatment.

  5. Evaluate the total bacterial count in urine samples.

    Time frame: After 3 months of intervention

    The total bacterial count in urine samples will be compared between groups of treatment.

  6. Evaluate the total bacterial count in urine samples.

    Time frame: After 6 months of intervention

    The total bacterial count in urine samples will be compared between groups of treatment.

Secondary outcomes

  1. Number of UTI episodes

    Time frame: After 3 and 6 months of intervention.

  2. Infection free participants (%)

    Time frame: After 6 months of intervention.

  3. Elapsed time until the 1st episode of UTI.

    Time frame: After 6 months of intervention.

  4. Elapsed time between the 1st and 2nd episode of UTI.

    Time frame: After 6 months of intervention.

  5. Elapsed time between the 2nd and 3rd episode of UTI.

    Time frame: After 6 months of intervention.

  6. Duration of UTI episodes.

    Time frame: After 6 months of intervention.

  7. The number of participants which associate sexual activity with the UTI episodes

    Time frame: After 6 months of intervention.

    The number of participants which associate sexual activity with the apperance of an UTI episode will be counted and compared between groups.

  8. Number of present symptoms during new UTI episodes.

    Time frame: After 6 months of intervention.

  9. Number of participants with dysuria.

    Time frame: After 6 months of intervention.

  10. Duration of dysuria.

    Time frame: After 6 months of intervention.

  11. Number of participants with pollakiuria

    Time frame: After 6 months of intervention.

  12. Duration of pollakiuria

    Time frame: After 6 months of intervention.

  13. Number of participants with urinary urgency.

    Time frame: After 6 months of intervention.

  14. Duration of urinary urgency.

    Time frame: After 6 months of intervention.

  15. Number of participants with tenesmus.

    Time frame: After 6 months of intervention.

  16. Duration of tenesmus.

    Time frame: After 6 months of intervention.

  17. Number of participants with hematuria.

    Time frame: After 6 months of intervention.

  18. Duration of hematuria

    Time frame: After 6 months of intervention.

  19. Number of participants with dyspareunia

    Time frame: After 6 months of intervention.

  20. Duration of dyspareunia

    Time frame: After 6 months of intervention.

  21. Number of participants with pelvic pain

    Time frame: After 6 months of intervention.

  22. Duration of pelvic pain

    Time frame: After 6 months of intervention.

  23. Number of participants with fever (Tª ≥ 38ºC).

    Time frame: After 6 months of intervention.

  24. Duration of fever (Tª ≥ 38ºC).

    Time frame: After 6 months of intervention.

  25. Number of participants with cloudy and smelly urine

    Time frame: After 6 months of intervention.

  26. Duration of cloudy and smelly urine

    Time frame: After 6 months of intervention.

  27. Number of antibiotics administered for the UTI episode.

    Time frame: After 6 months of intervention.

  28. Duration of antibiotic treatment for the UTI episode.

    Time frame: After 6 months of intervention.

  29. Number of antibiotic treatments administered during new UTI episodes.

    Time frame: After 6 months of intervention.

  30. Duration of antibiotic treatments administered during new UTI episodes.

    Time frame: After 6 months of intervention.

  31. Microbiome composition of stool samples determined by 16S sequencing.

    Time frame: After 6 months of intervention.

    The composition of fecal microbiome will be compared between treatments group and time

  32. Microbiota composition of urine samples determined by culture techniques.

    Time frame: After 6 months of intervention.

    The composition of urine microbiota will be compared between treatments group and time.

  33. Metabolomic profile of urine samples.

    Time frame: After 6 months of intervention.

Sponsors and collaborators

Lead sponsor

ProbiSearch SL

Industry

Registry information

Official study title

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).

Acronym: PROBUTI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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