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Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children

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ClinicalTrials.gov Identifier: NCT03462160
Recruitment Status : Unknown
Verified February 2018 by Medical University of Warsaw.
Recruitment status was:  Not yet recruiting
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Miralex Sp. z o.o.
Information provided by (Responsible Party):
Medical University of Warsaw

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prevention of Urinary Tract Infections in Children Other: Placebo control group Dietary Supplement: Probiotic experimental group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo supply for 90 days
Patients will receive placebo (in blinded sachets)
 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.
Experimental: Probiotic supply for 90 days
Patients will receive probiotics containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 (in blinded sachets).
 Dietary Supplement: Probiotic 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.


Outcome Measures
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Primary Outcome Measures :
  1. frequencies of recurrence of UTI [ Time Frame: 6 months after intervention ]
    New onset of symptomatic UTI within the 6 months follow-up period.


Secondary Outcome Measures :
  1. frequencies of hospitalization due to UTI [ Time Frame: 6 months after intervention ]
  2. the number of days of antibiotic therapy due to UTI [ Time Frame: 6 months after intervention ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462160


Contacts
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Contact: Maria Daniel, MD 696477117 ext 0048 maria.daniel@wum.edu.pl
Contact: Hanna Szymanik-Grzelak, PhD 223179656 ext 0048 h.szymanik@interia.pl

Locations
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Poland
Children's Hospital for The Medical University of Warsaw
Warsaw, Poland, 02-091
Sponsors and Collaborators
Medical University of Warsaw
Miralex Sp. z o.o.
Investigators
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Study Chair: Malgorzata Panczyk-Tomaszewska, Assistant Professor Medical University of Warsaw
Principal Investigator: Maria Daniel, MD Medical University of Warsaw
Principal Investigator: Hanna Szymanik-Grzelak, PhD Medical University of Warsaw
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03462160    
Other Study ID Numbers: UTI probiotic
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Warsaw:
Urinary Tract Infection
prophylaxis
probiotics
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases