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

Recurrent Urinary Tract Infection Clinical Trial

— PROBUTI  

Official 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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895578
• Other study ID #: UTI/23.01
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2023
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: ProbiSearch SL
• Contact: Susana Manzano Jiménez, PhD
• Phone: 918035179
• Email: susana.manzano[@]probisearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Recurrence
• Recurrent Urinary Tract Infection
• Urinary Tract Infections

Intervention

Dietary Supplement:
• Probiotic
1 capsule of probiotic (Lactobacillus CECT 9422 + Bifidobacterium CECT 30257) every 12 hours for 6-months.
• Probiotic + placebo
1 capsule of probiotic + 1 capsule of placebo per day for 6-months.
• Placebo
1 capsule of placebo every 12 hours for 6-months.

Locations

Country	Name	City	State
Spain	Hospital La Moraleja	Madrid
Spain	Hospital La Zarzuela	Madrid
Spain	Hospital San Francisco de Asís	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
ProbiSearch SL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	Evaluate the total bacterial count in urine samples.	The total bacterial count in urine samples will be compared between groups of treatment.	Before intervention
Primary	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
Primary	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	Number of UTI episodes		After 3 and 6 months of intervention.
Secondary	Infection free participants (%)		After 6 months of intervention.
Secondary	Elapsed time until the 1st episode of UTI.		After 6 months of intervention.
Secondary	Elapsed time between the 1st and 2nd episode of UTI.		After 6 months of intervention.
Secondary	Elapsed time between the 2nd and 3rd episode of UTI.		After 6 months of intervention.
Secondary	Duration of UTI episodes.		After 6 months of intervention.
Secondary	The number of participants which associate sexual activity with the UTI episodes	The number of participants which associate sexual activity with the apperance of an UTI episode will be counted and compared between groups.	After 6 months of intervention.
Secondary	Number of present symptoms during new UTI episodes.		After 6 months of intervention.
Secondary	Number of participants with dysuria.		After 6 months of intervention.
Secondary	Duration of dysuria.		After 6 months of intervention.
Secondary	Number of participants with pollakiuria		After 6 months of intervention.
Secondary	Duration of pollakiuria		After 6 months of intervention.
Secondary	Number of participants with urinary urgency.		After 6 months of intervention.
Secondary	Duration of urinary urgency.		After 6 months of intervention.
Secondary	Number of participants with tenesmus.		After 6 months of intervention.
Secondary	Duration of tenesmus.		After 6 months of intervention.
Secondary	Number of participants with hematuria.		After 6 months of intervention.
Secondary	Duration of hematuria		After 6 months of intervention.
Secondary	Number of participants with dyspareunia		After 6 months of intervention.
Secondary	Duration of dyspareunia		After 6 months of intervention.
Secondary	Number of participants with pelvic pain		After 6 months of intervention.
Secondary	Duration of pelvic pain		After 6 months of intervention.
Secondary	Number of participants with fever (Tª = 38ºC).		After 6 months of intervention.
Secondary	Duration of fever (Tª = 38ºC).		After 6 months of intervention.
Secondary	Number of participants with cloudy and smelly urine		After 6 months of intervention.
Secondary	Duration of cloudy and smelly urine		After 6 months of intervention.
Secondary	Number of antibiotics administered for the UTI episode.		After 6 months of intervention.
Secondary	Duration of antibiotic treatment for the UTI episode.		After 6 months of intervention.
Secondary	Number of antibiotic treatments administered during new UTI episodes.		After 6 months of intervention.
Secondary	Duration of antibiotic treatments administered during new UTI episodes.		After 6 months of intervention.
Secondary	Microbiome composition of stool samples determined by 16S sequencing.	The composition of fecal microbiome will be compared between treatments group and time	After 6 months of intervention.
Secondary	Microbiota composition of urine samples determined by culture techniques.	The composition of urine microbiota will be compared between treatments group and time.	After 6 months of intervention.
Secondary	Metabolomic profile of urine samples.		After 6 months of intervention.