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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Placebo | Placebo Comparator | Two capsules daily of Placebo supplement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | 1 capsule of probiotic (Lactobacillus CECT 9422 + Bifidobacterium CECT 30257) every 12 hours for 6-months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital La Moraleja | Madrid | Spain | ||||
| Hospital La Zarzuela |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 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. |
|
| 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. |
| Duration of UTI episodes. | After 6 months of intervention. |
| 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. |
| Number of present symptoms during new UTI episodes. | After 6 months of intervention. |
| Number of participants with dysuria. | After 6 months of intervention. |
| Duration of dysuria. | After 6 months of intervention. |
| Number of participants with pollakiuria | After 6 months of intervention. |
| Duration of pollakiuria | After 6 months of intervention. |
| Number of participants with urinary urgency. | After 6 months of intervention. |
| Duration of urinary urgency. | After 6 months of intervention. |
| Number of participants with tenesmus. | After 6 months of intervention. |
| Duration of tenesmus. | After 6 months of intervention. |
| Number of participants with hematuria. | After 6 months of intervention. |
| Duration of hematuria | After 6 months of intervention. |
| Number of participants with dyspareunia | After 6 months of intervention. |
| Duration of dyspareunia | After 6 months of intervention. |
| Number of participants with pelvic pain | After 6 months of intervention. |
| Duration of pelvic pain | After 6 months of intervention. |
| Number of participants with fever (Tª ≥ 38ºC). | After 6 months of intervention. |
| Duration of fever (Tª ≥ 38ºC). | After 6 months of intervention. |
| Number of participants with cloudy and smelly urine | After 6 months of intervention. |
| Duration of cloudy and smelly urine | After 6 months of intervention. |
| Number of antibiotics administered for the UTI episode. | After 6 months of intervention. |
| Duration of antibiotic treatment for the UTI episode. | After 6 months of intervention. |
| Number of antibiotic treatments administered during new UTI episodes. | After 6 months of intervention. |
| Duration of antibiotic treatments administered during new UTI episodes. | After 6 months of intervention. |
| 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. |
| 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. |
| Metabolomic profile of urine samples. | After 6 months of intervention. |
| Madrid |
| Spain |
| Hospital San Francisco de Asís | Madrid | Spain |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D019602 |
| Food and Beverages |