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Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children

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ClinicalTrials.gov Identifier: NCT03462160
Recruitment Status : 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

Tracking Information
First Submitted Date  ICMJE February 28, 2018
First Posted Date  ICMJE March 12, 2018
Last Update Posted Date March 12, 2018
Estimated Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
frequencies of recurrence of UTI [ Time Frame: 6 months after intervention ]
New onset of symptomatic UTI within the 6 months follow-up period.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
  • frequencies of hospitalization due to UTI [ Time Frame: 6 months after intervention ]
  • the number of days of antibiotic therapy due to UTI [ Time Frame: 6 months after intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children
Official Title  ICMJE Effectiveness of Prophylaxis of Urinary Tract Infections in Children With a Probiotic Containing Lactobacillus Rhamnosus PL1 and Lactobacillus Plantarum PM1, a Randomised Clinical Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Prevention of Urinary Tract Infections in Children
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: Placebo supply for 90 days
    Patients will receive placebo (in blinded sachets)
    Intervention: Other: Placebo control group
  • Experimental: Probiotic supply for 90 days
    Patients will receive probiotics containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 (in blinded sachets).
    Intervention: Dietary Supplement: Probiotic experimental group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2018)
106
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2019
Estimated Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maria Daniel, MD 696477117 ext 0048 maria.daniel@wum.edu.pl
Contact: Hanna Szymanik-Grzelak, PhD 223179656 ext 0048 h.szymanik@interia.pl
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03462160
Other Study ID Numbers  ICMJE UTI probiotic
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Medical University of Warsaw
Study Sponsor  ICMJE Medical University of Warsaw
Collaborators  ICMJE Miralex Sp. z o.o.
Investigators  ICMJE
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
PRS Account Medical University of Warsaw
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP