Trial | NCT03462160  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    106
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.
Study Started
Apr 01
2018
Anticipated
Primary Completion
Apr 01
2019
Anticipated
Study Completion
Sep 01
2019
Anticipated
Last Update
Mar 12
2018

Other Placebo control group

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.

Dietary Supplement Probiotic experimental group [lactobacillus plantarum, lactobacillus rhamnosus]

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.

Placebo supply for 90 days Placebo Comparator

Patients will receive placebo (in blinded sachets)

Probiotic supply for 90 days Experimental

Patients will receive probiotics containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 (in blinded sachets).

Criteria 

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
No Results Posted