Prevention of Urinary Tract Infections in Children
Conditions
Keywords
Urinary Tract Infection, prophylaxis, probiotics
Brief summary
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
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.
Interventions
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_SUPPLEMENTProbiotic experimental group
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.
Sponsors
Miralex Sp. z o.o.
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| frequencies of recurrence of UTI | 6 months after intervention | New onset of symptomatic UTI within the 6 months follow-up period. |
Secondary
| Measure | 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 |
Countries
Poland
Contacts
Primary ContactMaria Daniel, MD
Backup ContactHanna Szymanik-Grzelak, PhD
Outcome results
None listed