Probiotic supplement after bariatric surgery may improve the therapeutic effect of the surgery on the liver and may also improve the gastrointestinal outcomes, biochemical tests (e.g. B12, endotoxin levels), BO and weight loss after bariatric surgery. 5 . Subjects and methods 5.1 Study design: A randomized double blind controlled clinical trial with 6 months treatment and 6 months follow up, including 2 treatment arms: probiotic and placebo. In addition, a cross sectional study on nutrients intake, dietary pattern and the association with the microbiota profile among bariatric surgery candidates will be done . 5.2 Study population: patients who will undergo SG surgery through the bariatric surgery clinic at Assuta medical centers during 2014-2016 . Eligibility criteria : Subjects 18-65 years old BMI > 40 kg/m² or BMI > 35 kg/m² with comorbidities ( See Appendix 1 for the Ministry of health indications for bariatric surgeries) that got the bariatric commission approval of Assuta private hospitals to undergo sleeve gastrectomy surgery Willingness to take a probiotic/placebo supplement once a day for 6 months Ultrasound diagnosed NAFLD patients Reading and speaking Hebrew Exclusion criteria : Subject with mental illness or cognitive deterioration Use of probiotic/antibiotic 3 months before surgery Use of other antibiotic for more than 10 days during the study 7
Version 5/4.5.14 Drug addiction Excessive alcohol consumption (≥ 30 g/day in men or ≥ 20 g/day in women) Treatment with drugs known to cause hepatic steatosis or elevation of liver enzymes (e.g. Corticosteroids, HAART, Amiodarone, high dose estrogens) ( see Appendix 2 ) Treatment with drugs or supplements that may improve hepatic steatosis or liver enzymes (Vitamin E, Milk thistle, ω-3 fatty acid, Ursodeoxycholic acid) 3 months prior to the initiation of the study Other causes of chronic liver disease ( e.g. viral hepatitis: HBV/HCV +, autoimmune hepatitis, Hemochromatosis, Wilson's disease) Diabetic patients who are treated with antidiabetic medications, except diabetic patients who are treated for at least 6 months exclusively with Metformin at a stable dose Subjects who began a new lipid reduction medication less than 6 months prior to the initiation of the study Subjects with chronic conditions that could interfere with the study: active cancer, organ transplant subjects, advanced kidney or liver disease, inflammatory bowel disease and other systemic inflammatory conditions Bariatric surgery in the past 5.3 Sampling method: It would be a convenient sampling in which patients undergoing SG surgery through the bariatric surgery clinic at Assuta medical centers during 2014-2016, that are eligible according to the inclusion/exclusion criteria will be included. All eligible patients will get explanation about the research from the study investigators and if willing to participate will sign informed consent.
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- Fall '16
- Jeff Miller