Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Prevention of Urinary Tract Infections in Children||Other: Placebo control group Dietary Supplement: Probiotic experimental group||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
- frequencies of recurrence of UTI [ Time Frame: 6 months after intervention ]New onset of symptomatic UTI within the 6 months follow-up period.
- 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 ]
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
|Contact: Maria Daniel, MD||696477117 ext email@example.com|
|Contact: Hanna Szymanik-Grzelak, PhD||223179656 ext firstname.lastname@example.org|
|Children's Hospital for The Medical University of Warsaw|
|Warsaw, Poland, 02-091|
|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|