Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
Effect of Probiotics in the Treatment of Nonalcoholic Fatty Liver Disease
Evaluate the effect of supplementation of probiotics on liver changes (histological and enzymatic), lipid profile and gut microbiota of patients with nonalcoholic steatohepatitis (NASH).
Status | Recruiting |
Enrollment | 58 |
Est. completion date | January 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - 18 years, patients with NASH confirmed by biopsy within 6 months before inclusion. Exclusion Criteria: - Patients with hepatitis B virus, hepatitis C virus, alcohol consumption significantly (> 14 drinks per week for women and> 21 drinks per week for men) (Chalasani, 2012), history of decompensated liver disease (ascites, esophageal varices, encephalopathy), hepatocellular carcinoma, steroids, methotrexate, amiodarone, tamoxifen, valproate, vitamin E past 6 months, previous surgery (bariatric, gastric, intestinal resection), parenteral nutrition (TPN) the last 6 months, pregnancy or breastfeeding, history of hypothyroidism, Cushing's syndrome, diabetes type 1. |
Country | Name | City | State |
---|---|---|---|
Brazil | Irmandade Santa Casa de Misericórdia | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Federal University of Health Science of Porto Alegre | Irmandade Santa Casa de Misericórdia de Porto Alegre |
Brazil,
Aller R, De Luis DA, Izaola O, Conde R, Gonzalez Sagrado M, Primo D, De La Fuente B, Gonzalez J. Effect of a probiotic on liver aminotransferases in nonalcoholic fatty liver disease patients: a double blind randomized clinical trial. Eur Rev Med Pharmacol — View Citation
Loguercio C, Federico A, Tuccillo C, Terracciano F, D'Auria MV, De Simone C, Del Vecchio Blanco C. Beneficial effects of a probiotic VSL#3 on parameters of liver dysfunction in chronic liver diseases. J Clin Gastroenterol. 2005 Jul;39(6):540-3. — View Citation
Ma YY, Li L, Yu CH, Shen Z, Chen LH, Li YM. Effects of probiotics on nonalcoholic fatty liver disease: a meta-analysis. World J Gastroenterol. 2013 Oct 28;19(40):6911-8. doi: 10.3748/wjg.v19.i40.6911. Review. — View Citation
Shavakhi A, Minakari M, Firouzian H, Assali R, Hekmatdoost A, Ferns G. Effect of a Probiotic and Metformin on Liver Aminotransferases in Non-alcoholic Steatohepatitis: A Double Blind Randomized Clinical Trial. Int J Prev Med. 2013 May;4(5):531-7. — View Citation
Wong VW, Won GL, Chim AM, Chu WC, Yeung DK, Li KC, Chan HL. Treatment of nonalcoholic steatohepatitis with probiotics. A proof-of-concept study. Ann Hepatol. 2013 Mar-Apr;12(2):256-62. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hepatic changes (histological) | The assessment of fibrosis will be performed in all patients using noninvasive FIBROMAX test (evaluates fibrosis, inflammation and hepatic steatosis) for comparison with liver biopsy. | 6 months | |
Secondary | Hepatic changes (enzymatic) | The assessment of enzymatic activity will be performed in all patients via measurements of AST , ALT . | 6 months | |
Secondary | Lipid profile | The assessment of lipid profile will be performed in all patients via measurements of total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. | 6 months | |
Secondary | Alterations in gut microbiota | The evaluation of the intestinal microbiota will be performed in all patients by molecular analysis of stool dna test . | 6 months |
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