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IRCT20141208020249N3 IRCT 2018-10-08 Sanandaj University of Medical Sciences The role of probiotics in urinary tract infections prevention Evaluation of probiotics role in the prevention of urinary tract infection relapse after the first acute uncomplicated pyelonephritis in children 2018-06-17 anticipated 20 Complete https://irct.ir/trial/32471 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Envelope contains codeBefore starting a study, a series of envelopes are prepared based on the code available on the drug containers. The investigator and the patient are not aware of the concept of the code until the end of the study. Patients will select a package randomly at the time of the first visit and receive the medication, Blinding description: The medicines are packaged and encoded by a pharmacist out of study. Packages are delivered to the pharmacy for distribution to patients. The code on the packets remains outside the study until the analysis of the data is completed. N/A urinary tract infection. Intervention 1: Intervention group: Group A or study group are patients who receive probiotics Group A Prokid capsule (500mg) containing 3.5x 〖10〗 ^ 9 units Bifid bacterium lactys and 1x 〖10〗 ^ 9 lactobacillus acidophilus and 0.5x 〖10〗 ^ 9 lactobacillus rhamiosus and 1x 〖10〗 ^ 9 units of bifidobacterium bifidum. It is dissolved in water and delivered to the final dose 10 ^ 9 unit/ mL and taken at a dose of 0.5 mL / kg twice daily. Intervention 2: Control group: the B group or the control group are patients who receive placebo.Patients in the control group B also receive 0.5 mL / kg of body weight twice a day in pure water. Yes - There is a plan to make this available What will be shared: All data is from the proposal, raw data and project reports When: Data is available from the legal system six months after publication for two years To whom: All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences. Conditions: For legal issues and the need to use data in future studies Where to obtain: Rama Naghshizadian How to obtain: After submitting a request to the Kurdistan Research and Technology Dept. of Science and Technology, a call for submission is given. Comments:
public Behzad Khalafi
Vice Chancellor in Research Affair, Kurdistan University of Medical Sciences, Pasdaran Ave. Sanandaj
Sanandaj Iran (Islamic Republic of) 6617713446 +98 45 3344 9697 khalafi.behzad70@muk.ac.ir Sanandaj University of Medical Sciences scientific Rama Naghshidaian
Department of Pediatrics, Besat Hospital, Vakil Crossroad , Sanandaj
sanandaj Iran (Islamic Republic of) 0000000000 +98 87 3328 2004 R.nagshizadia@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Acute pyelonephritis Not history of urinary tract infections Not having urinary re flux Not having genitourinary system structural defects 6 month to 13 years old children 6 months 13 years Both within 48 hours treatment response failure patient and parents Dissatisfaction N39.0 Urinary tract infection, site not specified Treatment - Drugs Placebo Intervention group: Group A or study group are patients who receive probiotics Group A Prokid capsule (500mg) containing 3.5x 〖10〗 ^ 9 units Bifid bacterium lactys and 1x 〖10〗 ^ 9 lactobacillus acidophilus and 0.5x 〖10〗 ^ 9 lactobacillus rhamiosus and 1x 〖10〗 ^ 9 units of bifidobacterium bifidum. It is dissolved in water and delivered to the final dose 10 ^ 9 unit/ mL and taken at a dose of 0.5 mL / kg twice daily. Control group: the B group or the control group are patients who receive placebo.Patients in the control group B also receive 0.5 mL / kg of body weight twice a day in pure water. Urinary tract reinfection within 6 months. Timepoint: 6 month. Method of measurement: urine culture. Sanandaj University of Medical Sciences Approved 2018-08-19 Ethics committee of Kurdistan University of Medical Sciences pasdaran Blvd, opposite Shadi Hotel, Kurdistan University of Medical Sciences, Sanandaj, Management of Medical Researches and Information. POB 6617713446 sanandaj Kurdistan Iran (Islamic Republic of)