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IRCT20220104053626N3 IRCT 2022-02-22 Tabriz University of Medical Sciences The effect of probiotics in patients with non-alcoholic fatty liver disease Effects of Probiotic on IL6 and TNF-a levels on patients with nonalcoholic fatty liver disease 2022-03-16 anticipated 80 Complete https://irct.ir/trial/62070 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: From the patients who volunteered to participate in the study, 80 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. 2-3 Fatty Liver. Intervention 1: Intervention group: Patients will be included in this group after random allocation. All patients will receive routine treatment and, in addition to routine medications, will take probiotic pills twice daily for three months. Interleukin 6 levels will be measured before the intervention and after the intervention. Intervention 2: Control group: Patients will be included in this group after random allocation. All patients will receive routine treatment and, in addition to routine medications, will receive two placebo tablets daily for three months. Interleukin 6 levels will be measured before the intervention and after the intervention. 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 Masood Dinevari
Internal medicine department,Emam reza hospital,golgasht avenue,Daneshgah street
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 dinvarim@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Masood Dinevari
Internal medicine department,Emam reza hospital,golgasht avenue,Daneshgah street
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 dinvarim@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Grade two in terms of fatty liver grading Willingness to participate in the study no alcohol consumption age 18-75 18 years 75 years Both Take drugs with liver toxicity Recent 3 months of antibiotic use Hepatitis B and C cirrhosis pregnancy and lactation K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo Intervention group: Patients will be included in this group after random allocation. All patients will receive routine treatment and, in addition to routine medications, will take probiotic pills twice daily for three months. Interleukin 6 levels will be measured before the intervention and after the intervention. Control group: Patients will be included in this group after random allocation. All patients will receive routine treatment and, in addition to routine medications, will receive two placebo tablets daily for three months. Interleukin 6 levels will be measured before the intervention and after the intervention. Interleukin 6. Timepoint: Before the intervention and after the intervention. Method of measurement: Biochemical tests-ELISA. TNF-a level. Timepoint: before and after intervention. Method of measurement: ELISA. Tabriz University of Medical Sciences Approved 2022-01-19 Ethics committee of Tabriz University of Medical Sciences Golgasht Ave., emamreza hospital., Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)