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IRCT20220104053626N1 IRCT 2022-01-11 Tabriz University of Medical Sciences The effect of probiotics on non-alcoholic fatty liver Effect of Probiotics on elastographic findings of patients with nonalcoholic fatty liver disease 2021-02-28 anticipated 70 Complete https://irct.ir/trial/61156 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: From the patients who volunteered to participate in the study, 70 persons will be selected by simple random sampling. Randomization method: Randomization unit block: Individual Randomization layers: In each block, people will be matched based on age and gender. Random Allocation software: Random Allocation software How to create a random sequence: Using Random Allocation software Hide: The random sequence created is kept in a safe place and is done by an independent person who is not involved in the experiment during the study. Random allocation of hidden individuals, patients and researchers will not be aware of it, Blinding description: This study is a double-blind study in which the researcher of this study and the patients participating in the study will be unaware of the type of supplement received. Supplements will be provided to patients by another person who has no role in completing the questionnaire and performing blood tests. Patients will also be informed of the existence of two types of supplements (probiotics and placebo) when obtaining consent, but will be unaware of which study groups they will be included in. Placebo capsules are similar in appearance, color, and size to probiotic capsules. 1-2 Patients with non-alcoholic fatty liver disease diagnosed with ultrasound findings. Intervention 1: Intervention group: In addition to their usual medications, Rifaximin 550 mg tablets will be given twice a day for a week after one week of probiotics containing a combination of Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus casei, Bifidobacterium bruce, Lactobacillus acidophilus. , Bifidobacterium bifidum, Streptococcus thermophilus each will be in the amount (10 to the power of 9 CFU), as a probiotic will receive 2 times a day for 6 months Group. Intervention 2: Control group: In addition to their usual medications, Rifaximin 550 mg tablets will be given twice a day for a week. After one week, they will receive the starch capsule as a medicine twice a day for 6 months. Yes - There is a plan to make this available What will be shared: Only the results of the main outcome will be published in the form of an article When: Access period starts 6 months after the results are published To whom: After the article is published, everyone will have access to the results Conditions: After the article is published, everyone will have access to the results Where to obtain: After the article is published, everyone will have access to the results How to obtain: After the article is published, everyone will have access to the results Comments:
public Masood Dinevari
Internal medicine department,Emam reza hospital,golgasht avenue,Daneshgah street
Tabriz Iran (Islamic Republic of) 5164886994 +98 41 3334 7054 dinvarim@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Masoud Faghih Dinevari
Golgasht Ave., Emamreza Hospital
Tabriz Iran (Islamic Republic of) 5174666994 +98 41 3337 2084 masood.dinevari@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age 18 to 59 years Willingness to participate in the study No history of alcohol consumption Do not take drugs with liver toxicity 18 years 59 years Both Having liver disease with specific etiologies such as viral hepatitis Cirrhosis of the liver alcohol consumption Pregnancy and lactation Take other nutritional supplements Recent 3 months of antibiotic use K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: In addition to their usual medications, Rifaximin 550 mg tablets will be given twice a day for a week after one week of probiotics containing a combination of Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus casei, Bifidobacterium bruce, Lactobacillus acidophilus. , Bifidobacterium bifidum, Streptococcus thermophilus each will be in the amount (10 to the power of 9 CFU), as a probiotic will receive 2 times a day for 6 months Group Control group: In addition to their usual medications, Rifaximin 550 mg tablets will be given twice a day for a week. After one week, they will receive the starch capsule as a medicine twice a day for 6 months. Determination of the effect of probiotics on hepatic steatosis in patients with non-alcoholic fatty liver disease in comparison with the control group. Timepoint: After completing 6 months of treatment, patients will undergo elastography again and the degree of stasis will be determined based on LSM and CAP criteria. Pre- and post-intervention findings will be compared. Method of measurement: After treatment, patients will undergo elastography again and the degree of stasis will be determined based on LSM and CAP criteria. Pre- and post-intervention findings will be compared. Determination of the effect of probiotics on hepatic fibrosis in patients with non-alcoholic fatty liver disease in comparison with the control group. Timepoint: After completing 6 months of treatment, patients undergo elastography again and the degree of their liver fibrosis will be determined based on LSM and CAP criteria. The findings before and after the intervention will be compared. Method of measurement: After completing the treatment, the patients will undergo elastography again and their degree of liver fibrosis will be determined according to LSM and CAP criteria. The findings before and after the intervention will be compared. Tabriz University of Medical Sciences Approved 2021-04-12 Ethics committee of Tabriz University of Medical Sciences Golgasht Ave., emamreza hospital., Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)