]>
IRCT20220314054279N1 IRCT 2022-03-17 Kashan University of Medical Sciences The effect of probiotics on changes in liver enzymes, lipid factors and ultrasound evidence in children and adolescents aged 10 to 18 years with non-alcoholic fatty liver The effect of probiotics on changes in liver enzymes, lipid factors and ultrasound evidence in children and adolescents aged 10 to 18 years with non-alcoholic fatty liver 2021-01-20 anticipated 60 Complete https://irct.ir/trial/62478 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, the intervention group was coded with the letter A and the control group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists randomization list was prepared by selecting a sample size of 60 (two groups of 30) and permuted block randomization method (block size=4) (15 blocks of 4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups A or B. For example, suppose that in the first four blocks, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B and the same will continue until the last sample (60th person), Blinding description: In order to blind patients, the same drug (in terms of shape, size and color) will be prepared with the main drug. In order to blind the clinical caregiver (physicians or nutritionist), the drugs used for patients will be provided in coded form. 3 Non-alcoholic fatty liver disease. Intervention 1: Intervention group: Receive 500 mg Familact Capsules (Probiotic + Prebiotic) prepared from Zist Takhmir Company, once a day after meals for 8 weeks. Intervention 2: Control group: Receive placebo capsule (in the form of Familact drug without existing bacteria) prepared from Zist Takhmir company, once a day after meals for 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Maryam Naseri Taheri
No. 19, Erfan Alley, Mulla Mohsen St.
Kashan Iran (Islamic Republic of) 8718695737 +98 31 5531 9390 naseritaherii@gmail.com Kashan University of Medical Sciences scientific Dr. Davood Kheirkhah
Qutb Ravandi Boulevard, Shahid Beheshti Hospital
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5558 9333 kheirkhah_d@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Children and adolescents 10 to 18 years of age with non-alcoholic fatty liver disease confirmed by ultrasound and ALT more than 1.5 to 5 times normal 10 years 18 years Both Patients with alcoholic steatohepatitis Patients with systemic diseases (such as diabetes), inflammatory diseases, autoimmune diseases of the liver Positive serology of viral hepatitis Positive AMA ANA Positive Ceruloplasmin Children with hypothyroidism Taking nutritional supplements Other secondary causes of fatty liver Patients with any medication that affects the liver Liver enzyme levels are more than 6 times normal DB92 Non-alcoholic fatty liver disease Treatment - Drugs Placebo Intervention group: Receive 500 mg Familact Capsules (Probiotic + Prebiotic) prepared from Zist Takhmir Company, once a day after meals for 8 weeks Control group: Receive placebo capsule (in the form of Familact drug without existing bacteria) prepared from Zist Takhmir company, once a day after meals for 8 weeks Liver enzymes (ALT,AST). Timepoint: At the beginning of the study, 8 weeks after taking the drug. Method of measurement: blood test. Lipid factors (cholesterol, LDL, HDL). Timepoint: At the beginning of the study, 8 weeks after taking the drug. Method of measurement: blood test. Fatty liver grade. Timepoint: At the beginning of the study, 8 weeks after taking the drug. Method of measurement: Sonography. Body mass index. Timepoint: At the beginning of the study, 8 weeks after taking the drug. Method of measurement: Meters to measure height and scales to measure weight. Fasting blood sugar. Timepoint: At the beginning of the study, 8 weeks after taking the drug. Method of measurement: Blood test. Kashan University of Medical Sciences Approved 2020-11-11 Ethics committee of Kashan University of Medical Sciences Qutb Ravandi Boulevard - Kashan University of Medical Sciences kashan Isfehan Iran (Islamic Republic of)