Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children

Not Applicable

• Conditions: Prevention of Urinary Tract Infections in Children
• Interventions: Other: Placebo control group; Dietary Supplement: Probiotic experimental group

• Registration Number: NCT03462160
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-09
• Last Update Submitted: 2018-03-09
• Study First Posted: 2018-03-12
• Last Update Posted: 2018-03-12
• Study Start: 2018-04-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo supply for 90 days	Placebo control group	Patients will receive placebo (in blinded sachets)
Probiotic supply for 90 days	Probiotic experimental group	Patients will receive probiotics containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 (in blinded sachets).

Primary Outcome Measures

Name	Time	Method
frequencies of recurrence of UTI	6 months after intervention	New onset of symptomatic UTI within the 6 months follow-up period.

Secondary Outcome Measures

Name	Time	Method
frequencies of hospitalization due to UTI	6 months after intervention
the number of days of antibiotic therapy due to UTI	6 months after intervention

Trial Locations

Locations (1)

Children's Hospital for The Medical University of Warsaw; 🇵🇱 Warsaw, Poland