Ignite Creation Date:
2024-05-06 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03462160
Status:
UNKNOWN
Last Update Posted:
2018-03-12
First Post:
2018-02-28
Brief Title:
Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None