Clinical trial NCT05885373 - References

Non-Alcoholic Fatty Liver Disease — A Clinical Study to Evaluate the Effect of SIM01 in Female With NAFLD

Citation(s)

•   Abhari K, Saadati S, Yari Z, Hosseini H, Hedayati M, Abhari S, Alavian SM, Hekmatdoost A
  The effects of Bacillus coagulans supplementation in patients with non-alcoholic fatty liver disease: A randomized, placebo-controlled, clinical trial. Clin Nutr ESPEN. 2020 Oct;39:53-60. doi: 10.1016/j.clnesp.2020.06.020. Epub 2020 Jul 24.
•   Ahn SB, Jun DW, Kang BK, Lim JH, Lim S, Chung MJ
  Randomized, Double-blind, Placebo-controlled Study of a Multispecies Probiotic Mixture in Nonalcoholic Fatty Liver Disease. Sci Rep. 2019 Apr 5;9(1):5688. doi: 10.1038/s41598-019-42059-3.
•   Amarapurkar DN, Hashimoto E, Lesmana LA, Sollano JD, Chen PJ, Goh KL; Asia-Pacific Working Party on NAFLD
  How common is non-alcoholic fatty liver disease in the Asia-Pacific region and are there local differences? J Gastroenterol Hepatol. 2007 Jun;22(6):788-93. doi: 10.1111/j.1440-1746.2007.05042.x.
•   Arshad T, Golabi P, Paik J, Mishra A, Younossi ZM
  Prevalence of Nonalcoholic Fatty Liver Disease in the Female Population. Hepatol Commun. 2018 Nov 27;3(1):74-83. doi: 10.1002/hep4.1285. eCollection 2019 Jan.
•   Bakhshimoghaddam F, Shateri K, Sina M, Hashemian M, Alizadeh M
  Daily Consumption of Synbiotic Yogurt Decreases Liver Steatosis in Patients with Nonalcoholic Fatty Liver Disease: A Randomized Controlled Clinical Trial. J Nutr. 2018 Aug 1;148(8):1276-1284. doi: 10.1093/jn/nxy088.
•   Behrouz V, Aryaeian N, Zahedi MJ, Jazayeri S
  Effects of probiotic and prebiotic supplementation on metabolic parameters, liver aminotransferases, and systemic inflammation in nonalcoholic fatty liver disease: A randomized clinical trial. J Food Sci. 2020 Oct;85(10):3611-3617. doi: 10.1111/1750-3841.15367. Epub 2020 Sep 4.
•   Bellentani S, Scaglioni F, Marino M, Bedogni G
  Epidemiology of non-alcoholic fatty liver disease. Dig Dis. 2010;28(1):155-61. doi: 10.1159/000282080. Epub 2010 May 7.
•   Caldwell SH, Oelsner DH, Iezzoni JC, Hespenheide EE, Battle EH, Driscoll CJ
  Cryptogenic cirrhosis: clinical characterization and risk factors for underlying disease. Hepatology. 1999 Mar;29(3):664-9. doi: 10.1002/hep.510290347.
•   Chen Y, Feng R, Yang X, Dai J, Huang M, Ji X, Li Y, Okekunle AP, Gao G, Onwuka JU, Pang X, Wang C, Li C, Li Y, Sun C
  Yogurt improves insulin resistance and liver fat in obese women with nonalcoholic fatty liver disease and metabolic syndrome: a randomized controlled trial. Am J Clin Nutr. 2019 Jun 1;109(6):1611-1619. doi: 10.1093/ajcn/nqy358.
•   Chitturi S, Wong VW, Farrell G
  Nonalcoholic fatty liver in Asia: Firmly entrenched and rapidly gaining ground. J Gastroenterol Hepatol. 2011 Jan;26 Suppl 1:163-72. doi: 10.1111/j.1440-1746.2010.06548.x.
•   Chong CYL, Orr D, Plank LD, Vatanen T, O'Sullivan JM, Murphy R
  Randomised Double-Blind Placebo-Controlled Trial of Inulin with Metronidazole in Non-Alcoholic Fatty Liver Disease (NAFLD). Nutrients. 2020 Mar 27;12(4):937. doi: 10.3390/nu12040937.
•   DiStefano JK
  NAFLD and NASH in Postmenopausal Women: Implications for Diagnosis and Treatment. Endocrinology. 2020 Oct 1;161(10):bqaa134. doi: 10.1210/endocr/bqaa134.
•   Eslamparast T, Eghtesad S, Hekmatdoost A, Poustchi H
  Probiotics and Nonalcoholic Fatty liver Disease. Middle East J Dig Dis. 2013 Jul;5(3):129-36.
•   Farrell GC, Larter CZ
  Nonalcoholic fatty liver disease: from steatosis to cirrhosis. Hepatology. 2006 Feb;43(2 Suppl 1):S99-S112. doi: 10.1002/hep.20973.
•   Hamaguchi M, Kojima T, Ohbora A, Takeda N, Fukui M, Kato T
  Aging is a risk factor of nonalcoholic fatty liver disease in premenopausal women. World J Gastroenterol. 2012 Jan 21;18(3):237-43. doi: 10.3748/wjg.v18.i3.237.
•   Hamaguchi M, Kojima T, Takeda N, Nagata C, Takeda J, Sarui H, Kawahito Y, Yoshida N, Suetsugu A, Kato T, Okuda J, Ida K, Yoshikawa T
  Nonalcoholic fatty liver disease is a novel predictor of cardiovascular disease. World J Gastroenterol. 2007 Mar 14;13(10):1579-84. doi: 10.3748/wjg.v13.i10.1579.
•   Kobyliak N, Abenavoli L, Mykhalchyshyn G, Kononenko L, Boccuto L, Kyriienko D, Dynnyk O
  A Multi-strain Probiotic Reduces the Fatty Liver Index, Cytokines and Aminotransferase levels in NAFLD Patients: Evidence from a Randomized Clinical Trial. J Gastrointestin Liver Dis. 2018 Mar;27(1):41-49. doi: 10.15403/jgld.2014.1121.271.kby.
•   Loguercio C, De Simone T, Federico A, Terracciano F, Tuccillo C, Di Chicco M, Carteni M
  Gut-liver axis: a new point of attack to treat chronic liver damage? Am J Gastroenterol. 2002 Aug;97(8):2144-6. doi: 10.1111/j.1572-0241.2002.05942.x. No abstract available.
•   Manzhalii E, Virchenko O, Falalyeyeva T, Beregova T, Stremmel W
  Treatment efficacy of a probiotic preparation for non-alcoholic steatohepatitis: A pilot trial. J Dig Dis. 2017 Dec;18(12):698-703. doi: 10.1111/1751-2980.12561.
•   Miller ER 3rd, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E
  Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2005 Jan 4;142(1):37-46. doi: 10.7326/0003-4819-142-1-200501040-00110. Epub 2004 Nov 10.
•   Pandey KR, Naik SR, Vakil BV
  Probiotics, prebiotics and synbiotics- a review. J Food Sci Technol. 2015 Dec;52(12):7577-87. doi: 10.1007/s13197-015-1921-1. Epub 2015 Jul 22.
•   Rodriguez-Hernandez H, Cervantes-Huerta M, Rodriguez-Moran M, Guerrero-Romero F
  Decrease of aminotransferase levels in obese women is related to body weight reduction, irrespective of type of diet. Ann Hepatol. 2011 Oct-Dec;10(4):486-92.
•   Sanyal AJ, Chalasani N, Kowdley KV, McCullough A, Diehl AM, Bass NM, Neuschwander-Tetri BA, Lavine JE, Tonascia J, Unalp A, Van Natta M, Clark J, Brunt EM, Kleiner DE, Hoofnagle JH, Robuck PR; NASH CRN
  Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010 May 6;362(18):1675-85. doi: 10.1056/NEJMoa0907929. Epub 2010 Apr 28.
•   Soden JS, Devereaux MW, Haas JE, Gumpricht E, Dahl R, Gralla J, Traber MG, Sokol RJ
  Subcutaneous vitamin E ameliorates liver injury in an in vivo model of steatocholestasis. Hepatology. 2007 Aug;46(2):485-95. doi: 10.1002/hep.21690.
•   Solga SF, Diehl AM
  Non-alcoholic fatty liver disease: lumen-liver interactions and possible role for probiotics. J Hepatol. 2003 May;38(5):681-7. doi: 10.1016/s0168-8278(03)00097-7. No abstract available.
•   Wong VW, Chu WC, Wong GL, Chan RS, Chim AM, Ong A, Yeung DK, Yiu KK, Chu SH, Woo J, Chan FK, Chan HL
  Prevalence of non-alcoholic fatty liver disease and advanced fibrosis in Hong Kong Chinese: a population study using proton-magnetic resonance spectroscopy and transient elastography. Gut. 2012 Mar;61(3):409-15. doi: 10.1136/gutjnl-2011-300342. Epub 2011 Aug 16.
•   Wong VW, Wong GL, Yip GW, Lo AO, Limquiaco J, Chu WC, Chim AM, Yu CM, Yu J, Chan FK, Sung JJ, Chan HL
  Coronary artery disease and cardiovascular outcomes in patients with non-alcoholic fatty liver disease. Gut. 2011 Dec;60(12):1721-7. doi: 10.1136/gut.2011.242016. Epub 2011 May 20.
•   Yadav MK, Kumari I, Singh B, Sharma KK, Tiwari SK
  Probiotics, prebiotics and synbiotics: Safe options for next-generation therapeutics. Appl Microbiol Biotechnol. 2022 Jan;106(2):505-521. doi: 10.1007/s00253-021-11646-8. Epub 2022 Jan 11.

A Single-arm, Open-label Clinical Study to Evaluate the Effect of SIM01 in Female Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)

Details for clinical trial NCT05885373