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

NCT05895578 | Active Not Recruiting

• 1 other identifier: UTI/23.01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Recurrent Urinary Tract Infection

Outcome Measures

Primary Outcomes (6)

• Evaluate the number of participants with a positive urine culture

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

  Before intervention

• Evaluate the number of participants with a positive urine culture

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

  After 3 months of intervention.

• Evaluate the number of participants with a positive urine culture

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

  After 6 months of intervention.

• Evaluate the total bacterial count in urine samples.

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

  Before intervention

• Evaluate the total bacterial count in urine samples.

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

  After 3 months of intervention

• Evaluate the total bacterial count in urine samples.

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

  After 6 months of intervention

Secondary Outcomes (33)

• Number of UTI episodes

  After 3 and 6 months of intervention.

• Infection free participants (%)

  After 6 months of intervention.

• Elapsed time until the 1st episode of UTI.

  After 6 months of intervention.

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

  After 6 months of intervention.

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

  After 6 months of intervention.

Study Arms (3)

Probiotic

ACTIVE COMPARATOR

2 Capsule daily containing approximately 1\*10E9 colony forming unit (CFU) of Lactobacillus CECT 9422 +1\*10E9 colony forming unit (CFU) of Bifidobacterium CECT 30257.

Dietary Supplement: Probiotic

Probiotic + placebo

ACTIVE COMPARATOR

One capsule daily containing approximately 1\*10E9 colony forming unit (CFU) of Lactobacillus CECT 9422 +1\*10E9 colony forming unit (CFU) of Bifidobacterium CECT 30257 and 1 capsule of placebo supplement.

Dietary Supplement: Probiotic + placebo

Placebo

PLACEBO COMPARATOR

Two capsules daily of Placebo supplement.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Probiotic

Probiotic + placebo DIETARY_SUPPLEMENT

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

Probiotic + placebo

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• ProbiSearch SL: lead

Study Sites (3)

Hospital La Moraleja

Madrid, Spain

Location

Hospital La Zarzuela

Madrid, Spain

Location

Hospital San Francisco de Asís

Madrid, Spain

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 8, 2023
• Study Start: June 21, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-07

Locations

ES (3)