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IRCT20100524004010N23 IRCT 2018-04-18 Shahid Beheshti University of Medical Sciences Investigate the effects of synbiotic supplement containing Bacillus coagulans and inulin in the treatment of non-alcoholic fatty liver The effects of synbiotic supplement containing Bacillus coagulans and inulin on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis 2017-09-23 anticipated 50 Complete https://irct.ir/trial/28722 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomly assigned to receive synbiotic or placebo, Blinding description: Randomly assigned to intervention and placebo groups. N/A non alcoholic fatty liver disease. Intervention 1: Intervention group: 2 synbiotic capsule containing Bacillus coagulans(0.1) g and inulin(0.9 g) per day for 3 months. Intervention 2: Control group: 2 placebo capsule containing 1gram maltodextrin per day for 3 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is The patients information is private.
public Azita Hekmatdoost
West arghavan, Sanaat square, Farahzadi boulvard, Qods Town
Tehran Iran (Islamic Republic of) 00 +98 912 306 5084 A_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azita Hekmatdoost
West arghavan, Sanaat square, Farahzadi boulvard, Qods Town
Tehran Iran (Islamic Republic of) 11 +98 912 306 5084 A_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria for the study: Age >18 years old; Fill out the form consent and approve it; Controlled Attenuation Parameter (CAP score)>263; Having a history of alcohol consumption less than 10 mg per day in women and less than 20 mg per day in men; Absence of other acute and chronic diseases and disorders of the liver (hepatitis B, C, etc.), biliary disease, known autoimmune diseases, cancer and inherited disorders affecting liver condition (storage disease of iron, and copper. ..); Absence of Hypertension, cardio - vascular diseases, lung disease and kidney disease, cirrhosis and celiac disease; Absence of pregnancy or lactation, athletes or hospitalization; Not consume medications such as metformin, vitamin E and Ursodeoxycholic Acid (UDCA); Not consume hepatotoxic drugs such as phenytoin, tamoxifen and lithium and corticosteroids and methotrexate; Not consume medications of antibiotics over a week during the study period or before entering it; No history of weight loss surgery in the past year the 3-month weight loss program; No history of hypothyroidism, Cushing's syndrome and diabetes , lack of gall bladder disease. Exclusion Criteria for the study: Food intolerance and unlikely side effects from taking supplements; pregnancy.. 18 years no limit Both Other spec K75.8 Treatment - Other Treatment - Other Intervention group: 2 synbiotic capsule containing Bacillus coagulans(0.1) g and inulin(0.9 g) per day for 3 months Control group: 2 placebo capsule containing 1gram maltodextrin per day for 3 months LDL-C. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits. Total cholestrol. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits. HDL-C. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits. TG. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits. FBS. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits. Serum insulin. Timepoint: Begining and end of intervention. Method of measurement: Radioimmunoassay. AST. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits. ALT. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits. HOMA. Timepoint: Begining and end of intervention. Method of measurement: Calculation. TNF-α. Timepoint: Begining and end of intervention. Method of measurement: Elisa. Steatosis. Timepoint: Begining and end of intervention. Method of measurement: ultrasonography. Fibrosis. Timepoint: Begining and end of intervention. Method of measurement: fibroscan. SFA. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day. MUFA. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day. PUFA. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day. Carbohydrate intake. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day. Protein intake. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day. Fat intake. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day. Shahid Beheshti University of Medical Sciences Approved 2017-11-15 National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sci West arghavan, Sanaat square, Farahzadi boulvard, Shahrake gharb Tehran Tehran Iran (Islamic Republic of)