Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children

Study Overview
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Brief Summary
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The investigators aim to assess the effectiveness of prophylaxis of urinary tract infections in children with a probiotic containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1. It is formulated a hypothesis that a 3-months course of probiotic prophylasis is more effective than placebo.

Detailed Description
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In previously published European and global guidelines, there has been no consensus among experts regarding the prophylaxis of recurrence urinary tract infections. Depending on the recommendation, the prevention of recurrence UTI should be used, not justified, or should be used in special cases. However, preparations that will be effective in preventing UTI and will not cause bacterial resistance are still sought. 106 patients aged 3 to 18 years with recurrence UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) or children with ≥1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors (congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls) will be randomly assigned to receive a 90-days prophylaxsis arm (probiotic UroLact containing Lactobacillus Rhamnosus PL1 and Lactobacillus Plantarum PM1) or a 90-days placebo arms. The primary outcome measure will be frequencies of recurrence of UTI during the 6 months after the intervention.

Official Title
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Effectiveness of Prophylaxis of Urinary Tract Infections in Children With a Probiotic Containing Lactobacillus Rhamnosus PL1 and Lactobacillus Plantarum PM1, a Randomised Clinical Trial

Conditions
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Prevention of Urinary Tract Infections in Children

Intervention / Treatment
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* Other: Placebo control group
* Dietary Supplement: Probiotic experimental group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: recurrent UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) OR 1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors: congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls ≥1 episode of urinary tract infection in the last 6 months Exclusion Criteria: intake of probiotic preparations for ≥1 month in the last 3 months known allergy to the study products immunosuppression therapy disease with immune deficiency children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo supply for 90 days<br>Patients will receive placebo (in blinded sachets) | Other: Placebo control group<br>* Placebo will be administered orally, after dissolving the sachet in lukewarm water, every evening during the meal. The placebo appearance will be similar to the probiotic.<br>|
| Experimental: Probiotic supply for 90 days<br>Patients will receive probiotics containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 (in blinded sachets). | Dietary Supplement: Probiotic experimental group<br>* Probiotic UroLact containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 will be administered orally, after dissolving the sachet in lukewarm water, every evening during the meal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequencies of recurrence of UTI | New onset of symptomatic UTI within the 6 months follow-up period. | 6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequencies of hospitalization due to UTI |  | 6 months after intervention | 
| the number of days of antibiotic therapy due to UTI |  | 6 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Tract Infection, prophylaxis, probiotics