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

Primary Purpose

Recurrent Urinary Tract Infection

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Probiotic
Probiotic + placebo
Placebo
Sponsored by
ProbiSearch SL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Urinary Tract Infection

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Adult women with aged between 18 and 50 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 72 hours, 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.

Sites / Locations

  • Hospital San Francisco de AsísRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Probiotic + placebo

Placebo

Arm Description

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.

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.

Two capsules daily of Placebo supplement.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of UTI episodes
Infection free participants (%)
Elapsed time until the 1st episode of UTI.
Elapsed time between the 1st and 2nd episode of UTI.
Elapsed time between the 2nd and 3rd episode of UTI.
Duration of UTI episodes.
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.
Number of present symptoms during new UTI episodes.
Number of participants with dysuria.
Duration of dysuria.
Number of participants with pollakiuria
Duration of pollakiuria
Number of participants with urinary urgency.
Duration of urinary urgency.
Number of participants with tenesmus.
Duration of tenesmus.
Number of participants with hematuria.
Duration of hematuria
Number of participants with dyspareunia
Duration of dyspareunia
Number of participants with pelvic pain
Duration of pelvic pain
Number of participants with fever (Tª ≥ 38ºC).
Duration of fever (Tª ≥ 38ºC).
Number of participants with cloudy and smelly urine
Duration of cloudy and smelly urine
Number of antibiotics administered for the UTI episode.
Duration of antibiotic treatment for the UTI episode.
Number of antibiotic treatments administered during new UTI episodes.
Duration of antibiotic treatments administered during new UTI episodes.
Microbiome composition of stool samples determined by 16S sequencing.
The composition of fecal microbiome will be compared between treatments group and time
Microbiota composition of urine samples determined by culture techniques.
The composition of urine microbiota will be compared between treatments group and time.
Metabolomic profile of urine samples.

Full Information

First Posted
May 19, 2023
Last Updated
June 21, 2023
Sponsor
ProbiSearch SL
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1. Study Identification

Unique Protocol Identification Number
NCT05895578
Brief Title
Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
Acronym
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).
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProbiSearch SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Urinary Tract Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Probiotic + placebo
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two capsules daily of Placebo supplement.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
1 capsule of probiotic (Lactobacillus CECT 9422 + Bifidobacterium CECT 30257) every 12 hours for 6-months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic + placebo
Intervention Description
1 capsule of probiotic + 1 capsule of placebo per day for 6-months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
1 capsule of placebo every 12 hours for 6-months.
Primary Outcome Measure Information:
Title
Evaluate the number of participants with a positive urine culture
Description
The number of participants with a positive urine culture will be compared between groups of treatment.
Time Frame
Before intervention
Title
Evaluate the number of participants with a positive urine culture
Description
The number of participants with a positive urine culture will be compared between groups of treatment.
Time Frame
After 3 months of intervention.
Title
Evaluate the number of participants with a positive urine culture
Description
The number of participants with a positive urine culture will be compared between groups of treatment.
Time Frame
After 6 months of intervention.
Title
Evaluate the total bacterial count in urine samples.
Description
The total bacterial count in urine samples will be compared between groups of treatment.
Time Frame
Before intervention
Title
Evaluate the total bacterial count in urine samples.
Description
The total bacterial count in urine samples will be compared between groups of treatment.
Time Frame
After 3 months of intervention
Title
Evaluate the total bacterial count in urine samples.
Description
The total bacterial count in urine samples will be compared between groups of treatment.
Time Frame
After 6 months of intervention
Secondary Outcome Measure Information:
Title
Number of UTI episodes
Time Frame
After 3 and 6 months of intervention.
Title
Infection free participants (%)
Time Frame
After 6 months of intervention.
Title
Elapsed time until the 1st episode of UTI.
Time Frame
After 6 months of intervention.
Title
Elapsed time between the 1st and 2nd episode of UTI.
Time Frame
After 6 months of intervention.
Title
Elapsed time between the 2nd and 3rd episode of UTI.
Time Frame
After 6 months of intervention.
Title
Duration of UTI episodes.
Time Frame
After 6 months of intervention.
Title
The number of participants which associate sexual activity with the UTI episodes
Description
The number of participants which associate sexual activity with the apperance of an UTI episode will be counted and compared between groups.
Time Frame
After 6 months of intervention.
Title
Number of present symptoms during new UTI episodes.
Time Frame
After 6 months of intervention.
Title
Number of participants with dysuria.
Time Frame
After 6 months of intervention.
Title
Duration of dysuria.
Time Frame
After 6 months of intervention.
Title
Number of participants with pollakiuria
Time Frame
After 6 months of intervention.
Title
Duration of pollakiuria
Time Frame
After 6 months of intervention.
Title
Number of participants with urinary urgency.
Time Frame
After 6 months of intervention.
Title
Duration of urinary urgency.
Time Frame
After 6 months of intervention.
Title
Number of participants with tenesmus.
Time Frame
After 6 months of intervention.
Title
Duration of tenesmus.
Time Frame
After 6 months of intervention.
Title
Number of participants with hematuria.
Time Frame
After 6 months of intervention.
Title
Duration of hematuria
Time Frame
After 6 months of intervention.
Title
Number of participants with dyspareunia
Time Frame
After 6 months of intervention.
Title
Duration of dyspareunia
Time Frame
After 6 months of intervention.
Title
Number of participants with pelvic pain
Time Frame
After 6 months of intervention.
Title
Duration of pelvic pain
Time Frame
After 6 months of intervention.
Title
Number of participants with fever (Tª ≥ 38ºC).
Time Frame
After 6 months of intervention.
Title
Duration of fever (Tª ≥ 38ºC).
Time Frame
After 6 months of intervention.
Title
Number of participants with cloudy and smelly urine
Time Frame
After 6 months of intervention.
Title
Duration of cloudy and smelly urine
Time Frame
After 6 months of intervention.
Title
Number of antibiotics administered for the UTI episode.
Time Frame
After 6 months of intervention.
Title
Duration of antibiotic treatment for the UTI episode.
Time Frame
After 6 months of intervention.
Title
Number of antibiotic treatments administered during new UTI episodes.
Time Frame
After 6 months of intervention.
Title
Duration of antibiotic treatments administered during new UTI episodes.
Time Frame
After 6 months of intervention.
Title
Microbiome composition of stool samples determined by 16S sequencing.
Description
The composition of fecal microbiome will be compared between treatments group and time
Time Frame
After 6 months of intervention.
Title
Microbiota composition of urine samples determined by culture techniques.
Description
The composition of urine microbiota will be compared between treatments group and time.
Time Frame
After 6 months of intervention.
Title
Metabolomic profile of urine samples.
Time Frame
After 6 months of intervention.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult women with aged between 18 and 50 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 72 hours, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susana Manzano Jiménez, PhD
Phone
918035179
Email
susana.manzano@probisearch.com
Facility Information:
Facility Name
Hospital San Francisco de Asís
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Ángel Espinosa, MD

12. IPD Sharing Statement

Learn more about this trial

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

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