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IRCT20210620051628N1 IRCT 2021-07-13 Hamedan University of Medical Sciences Evaluation of the effect of probiotic prophylaxis in children with nephrotic syndrome Evaluation of the effectiveness of probiotic( lactobacillus reuteri )on the course of the disease and response to treatment of children with nephrotic syndrome. 2021-08-23 anticipated 48 Complete https://irct.ir/trial/57123 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Alternative block randomization method was used. Random units were children with nephrotic syndrome. R statistical software will be used to generate randomized blocks in this clinical trial. In this software, Blockrand () function was used for random allocation. Using this function, random designs are generated and individuals are assigned to the treatment or control group based on the blocks produced. For example, in the quadruple block of ABAB, the first and third patients to group A, and the second and fourth patients to treatment B. Are allocated. In this study, 12 blocks of 4 will be used. [We have shown the classical therapy group with the symbol "B" and the probiotic therapy group with the symbol "A"], Blinding description: The control group is treated with prednisone. The prednisone and probiotic treatment group, which is similar in structure, shape, color, and odor to the control group, and the drugs are indistinguishable in appearance. Due to the fact that patients are randomly assigned to groups, patients are not aware of the assigned treatment. In this study, participants enter the study based on designated blocks and without knowing the placement in groups. Patients are unaware of being placed in groups, but the facilitator (researcher) is aware of how to place and group. N/A nephrotic syndrome. Intervention 1: Intervention group:probiotic is administered orally from rotflore sachet (containing 10 to 8 rotary lactobacilli per sachet) daily. Intervention 2: Control group: In this group, patients with idiopathic nephrotic syndrome are treated only with classical treatment includes prednisone from Iran Hormone Pharmaceutical Company ,60mg/m2/day. Yes - There is a plan to make this available What will be shared: The results of this study are published in the title of the dissertation and the subsequent paper by Hamadan University of Medical Sciences. When: From 2023, access was provided. To whom: n Researchers, physicians, nurses and medical students Conditions: En Use the findings to improve patient care and develop research strategies. Where to obtain: En Hamadan University of Medical Science How to obtain: En Consult the Hamadan University of Medical Sciences' Central Library. Comments:
public Gholamreza Kalvandi
Hamadan Shahid Fahmideh Blvd. Hamadan University of Medical Sciences
hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0426 g.kalvandi@umsha.ac.ir Hamedan University of Medical Sciences scientific Rahimpour Amiri
Hamadan Shahid Fahmideh Blvd. Hamadan University of Medical Sciences
hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0426 r.amiri@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) All children 2 to 14 years old who are diagnosed with idiopathic nephrotic syndrome are referred to the pediatric nephrology clinic of Besat Hospital and their disease is approved by a pediatric nephrologist based on diagnostic criteria. 2 years 14 years Both congenital nephrotic syndrome Secondary nephrotic syndrome Associated with glomerulonephritis (nephrotic nephrotic syndrome) Accompanied by kidney failure Accompanied by high blood pressure Start antibiotics for any reason Age less than 2 years and more than 14 years Dissatisfaction N04 Nephrotic syndrome Prevention Prevention Intervention group:probiotic is administered orally from rotflore sachet (containing 10 to 8 rotary lactobacilli per sachet) daily Control group: In this group, patients with idiopathic nephrotic syndrome are treated only with classical treatment includes prednisone from Iran Hormone Pharmaceutical Company ,60mg/m2/day Follow-up of relapse and treatment of patients. Timepoint: MONTHLY. Method of measurement: Presence or absence of proteinuria. Recurrence of nephrotic syndrome in treated patients. Timepoint: En MONTHLY. Method of measurement: Presence of protein in urine. Hamedan University of Medical Sciences Approved 2021-07-05 Ethics committee of Hamadan University of Medical Sciences Hamadan University of Medical Sciences, Shahid Fahmideh Blvd Hamadan Hamadan Iran (Islamic Republic of)