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IRCT20211028052897N1 IRCT 2022-03-13 Zanjan University of Medical Sciences The effect of probiotics in the treatment of urinary tract infections in children 6 months to 12 years The effect of probiotics in the treatment of urinary tract infections in children 6 months to 12 years 2021-10-31 anticipated 48 Complete https://irct.ir/trial/59669 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples Will be selected from 48 patients aged 6 months to 12 years with a diagnosis of urinary tract infection admitted to the pediatric ward in Ayatollah Mousavi Hospital, Zanjan University of Medical Sciences. Individuals are randomly divided into two groups receiving probiotic drug (pedilact) and the control group. Random allocation will be considered as Block permutation Randomization with four blocks including AABB-BBAA-BABA-ABAB-BAAB-ABBA and individuals will be assigned to intervention or control groups based on these blocks (which will be randomly selected). 3 Urinary tract infection. Intervention 1: Intervention group: In addition to routine treatments , they will receive probiotics for 5 days (5 drops per day for children under 2 years and 15 drops daily for children older than 2 years). Intervention 2: Control group: They will only receive routine treatments that include intravenous ceftriaxone at a dose of 50 mg / kg / day to 75 mg / kg / day. Yes - There is a plan to make this available What will be shared: After completing the study, there is a plan to share non-identifiable individual data of the participants, the study protocol, the statistical analysis of the data, the informed consent form patents, clinical reports, analysis codes, and data coding systems (Dictionary). When: The start of the access period to the data of this study will be from Early 2023 and approximately 6 months after the publication of the results. To whom: The data of this study are possible for all Families of children have a urinary tract infection and are hospitalized in the pediatric ward, and especially those working in health care systems. Conditions: The researcher wants to use the data to improve of children with urinary tract infections. Where to obtain: To receive information anyone can be use the following email: moezi@zums.ac.ir How to obtain: After sending the message and introducing herself or himself and the reason for the need for data, the applicant will be provided with the information after confirmation. Comments:
public Farzaneh Moezi
Ayatollah Mousavi Hospital, Gavazang Street,Pro. Soboti Blv, Zanjan, Iran
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 moezi@zums.ac.ir Zanjan University of Medical Sciences scientific Farzaneh Moezi
Ayatollah Mousavi hospital, Gavazang Street, Pro. Soboti Blv, Zanjan, Iran
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 moezi@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) All patients 6 months to 12 years with diagnosis of urinary tract infection (urine analysis and positive urine culture) Lack of allergy of the patient to probiotic drug (pedilact) Willingness to participate in the study 6 months 12 years Both Renal anomalies Having any type of immunodeficiency Having a UTI and another infectious disease at the same time Emphysematous pyelonephritis Allergy to probiotic drug (pedilact) or intolerance to it N39.0 Urinary tract infection, site not specified Treatment - Drugs Treatment - Drugs Intervention group: In addition to routine treatments , they will receive probiotics for 5 days (5 drops per day for children under 2 years and 15 drops daily for children older than 2 years). Control group: They will only receive routine treatments that include intravenous ceftriaxone at a dose of 50 mg / kg / day to 75 mg / kg / day. Improve the symptoms of urinary tract infection. Timepoint: 2 and 5 days after starting Probiotic treatment (pedilact). Method of measurement: Urine culture. Zanjan University of Medical Sciences Approved 2021-08-24 Ethics Committee of Deputy of Research and Technology of Zanjan University of Medical Sciences Deputy of Research and Technology, third floor, Second building, Central Headquarters of Zanjan University of Medical Sciences, The beginning of Jomhuri Eslami Boulevard, Azadi Blv, Zanjan, Iran Zanjan Zanjan Iran (Islamic Republic of)