Status:
UNKNOWN
Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children
Lead Sponsor:
Medical University of Warsaw
Collaborating Sponsors:
Miralex Sp. z o.o.
Conditions:
Prevention of Urinary Tract Infections in Children
Eligibility:
All Genders
3-18 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT03462160
Start Date
April 1 2018
End Date
September 1 2019
Last Update
March 12 2018
Active Locations (1)
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1
Children's Hospital for The Medical University of Warsaw
Warsaw, Poland, 02-091