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Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children

NCT03462160 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2018-03-12

No results posted yet for this study

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.

Conditions

  • Prevention of Urinary Tract Infections in Children

Interventions

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.

Sponsors & Collaborators

  • Miralex Sp. z o.o.

    collaborator UNKNOWN

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Malgorzata Panczyk-Tomaszewska, Assistant Professor · Medical University of Warsaw

  • Maria Daniel, MD · Medical University of Warsaw

  • Hanna Szymanik-Grzelak, PhD · Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2019-04-01
Completion
2019-09-01

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03462160 on ClinicalTrials.gov