Clinical trial NCT05895578: Effect of a Probiotic on the Urinary Tract Microbiota of Participants with Recurrent Urinary Tract Infection.
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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Urinary Tract Infection
Lead sponsor: ProbiSearch SL
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Evaluate the number of participants with a positive urine culture
timeFrame: Before intervention
measure: Evaluate the number of participants with a positive urine culture
timeFrame: After 3 months of intervention.
measure: Evaluate the number of participants with a positive urine culture
timeFrame: After 6 months of intervention.
measure: Evaluate the total bacterial count in urine samples.
timeFrame: Before intervention
measure: Evaluate the total bacterial count in urine samples.
timeFrame: After 3 months of intervention
measure: Evaluate the total bacterial count in urine samples.
timeFrame: After 6 months of intervention
Secondary outcomes:
measure: Number of UTI episodes
timeFrame: After 3 and 6 months of intervention.
measure: Infection free participants (%)
timeFrame: After 6 months of intervention.
measure: Elapsed time until the 1st episode of UTI.
timeFrame: After 6 months of intervention.
measure: Elapsed time between the 1st and 2nd episode of UTI.
timeFrame: After 6 months of intervention.
measure: Elapsed time between the 2nd and 3rd episode of UTI.
timeFrame: After 6 months of intervention.
measure: Duration of UTI episodes.
timeFrame: After 6 months of intervention.
measure: The number of participants which associate sexual activity with the UTI episodes
timeFrame: After 6 months of intervention.
measure: Number of present symptoms during new UTI episodes.
timeFrame: After 6 months of intervention.
measure: Number of participants with dysuria.
timeFrame: After 6 months of intervention.
measure: Duration of dysuria.
timeFrame: After 6 months of intervention.
measure: Number of participants with pollakiuria
timeFrame: After 6 months of intervention.
measure: Duration of pollakiuria
timeFrame: After 6 months of intervention.
measure: Number of participants with urinary urgency.
timeFrame: After 6 months of intervention.
measure: Duration of urinary urgency.
timeFrame: After 6 months of intervention.
measure: Number of participants with tenesmus.
timeFrame: After 6 months of intervention.
measure: Duration of tenesmus.
timeFrame: After 6 months of intervention.
measure: Number of participants with hematuria.
timeFrame: After 6 months of intervention.
measure: Duration of hematuria
timeFrame: After 6 months of intervention.
measure: Number of participants with dyspareunia
timeFrame: After 6 months of intervention.
measure: Duration of dyspareunia
timeFrame: After 6 months of intervention.
measure: Number of participants with pelvic pain
timeFrame: After 6 months of intervention.
measure: Duration of pelvic pain
timeFrame: After 6 months of intervention.
measure: Number of participants with fever (Tª ≥ 38ºC).
timeFrame: After 6 months of intervention.
measure: Duration of fever (Tª ≥ 38ºC).
timeFrame: After 6 months of intervention.
measure: Number of participants with cloudy and smelly urine
timeFrame: After 6 months of intervention.
measure: Duration of cloudy and smelly urine
timeFrame: After 6 months of intervention.
measure: Number of antibiotics administered for the UTI episode.
timeFrame: After 6 months of intervention.
measure: Duration of antibiotic treatment for the UTI episode.
timeFrame: After 6 months of intervention.
measure: Number of antibiotic treatments administered during new UTI episodes.
timeFrame: After 6 months of intervention.
measure: Duration of antibiotic treatments administered during new UTI episodes.
timeFrame: After 6 months of intervention.
measure: Microbiome composition of stool samples determined by 16S sequencing.
timeFrame: After 6 months of intervention.
measure: Microbiota composition of urine samples determined by culture techniques.
timeFrame: After 6 months of intervention.
measure: Metabolomic profile of urine samples.
timeFrame: After 6 months of intervention.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital La Moraleja
city: Madrid
country: Spain
facility: Hospital La Zarzuela
city: Madrid
country: Spain
facility: Hospital San Francisco de Asís
Study officials:
References: