Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children
Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children
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.
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.
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