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