Safety and long-term effect of the probiotic FK-23 in patients with hepatitis C virus infection
A clinical trial was conducted on 39 adult HCV-positive subjects to determine the safety and long-term effect of the probiotic FK-23 (heat-treated Enterococcus faecalis strain FK-23). Asymptomatic anti-HCV positive adults who fulfilled the selection criteria and gave voluntary consent were recruited...
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| Published in | Bioscience of Microbiota, Food and Health Vol. 35; no. 3; pp. 123 - 128 |
|---|---|
| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Japan
BMFH Press
2016
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| Subjects | |
| Online Access | Get full text |
| ISSN | 2186-3342 2186-6953 2186-3342 |
| DOI | 10.12938/bmfh.2015-024 |
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| Abstract | A clinical trial was conducted on 39 adult HCV-positive subjects to determine the safety and long-term effect of the probiotic FK-23 (heat-treated Enterococcus faecalis strain FK-23). Asymptomatic anti-HCV positive adults who fulfilled the selection criteria and gave voluntary consent were recruited from attendees of the Hepatitis Carrier Clinic, Department of Medical Research (Lower Myanmar). Each subject was given 2,700 mg of FK-23 per day by oral route. Blood samples were taken at enrollment and every 3 months and tested for alanine aminotransferase (ALT) and aspartate transaminase (AST). Viral load, urea, total protein, hemoglobin and platelet count were determined every 6 months. Among the subjects, 23 completed 36 months, 31 completed 24 months, 35 completed 12 months and 37 completed 6 months of probiotic therapy. Significant decreases in mean ALT levels were observed at 3 months (34. 9 ± 15.1 IU/l) as compared with the initial level (64.8 ± 17.5 IU/l) and persisted up to 36 months (43.7 ± 25.2 IU/l). Decrease of AST was detected after 9 months (46.2 ± 21.7 IU/l) of probiotic therapy as compared with the initial level (64.3 ± 28.7 IU/l). FK-23 was safe based on the stable levels of biochemical and hematological parameters and the absence of untoward side effects. The FK-23 preparation was well tolerated and accepted by the subjects. |
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| AbstractList | A clinical trial was conducted on 39 adult HCV-positive subjects to determine the safety and long-term effect of the probiotic FK-23 (heat-treated Enterococcus faecalis strain FK-23). Asymptomatic anti-HCV positive adults who fulfilled the selection criteria and gave voluntary consent were recruited from attendees of the Hepatitis Carrier Clinic, Department of Medical Research (Lower Myanmar). Each subject was given 2,700 mg of FK-23 per day by oral route. Blood samples were taken at enrollment and every 3 months and tested for alanine aminotransferase (ALT) and aspartate transaminase (AST). Viral load, urea, total protein, hemoglobin and platelet count were determined every 6 months. Among the subjects, 23 completed 36 months, 31 completed 24 months, 35 completed 12 months and 37 completed 6 months of probiotic therapy. Significant decreases in mean ALT levels were observed at 3 months (34. 9 ± 15.1 IU/l) as compared with the initial level (64.8 ± 17.5 IU/l) and persisted up to 36 months (43.7 ± 25.2 IU/l). Decrease of AST was detected after 9 months (46.2 ± 21.7 IU/l) of probiotic therapy as compared with the initial level (64.3 ± 28.7 IU/l). FK-23 was safe based on the stable levels of biochemical and hematological parameters and the absence of untoward side effects. The FK-23 preparation was well tolerated and accepted by the subjects.A clinical trial was conducted on 39 adult HCV-positive subjects to determine the safety and long-term effect of the probiotic FK-23 (heat-treated Enterococcus faecalis strain FK-23). Asymptomatic anti-HCV positive adults who fulfilled the selection criteria and gave voluntary consent were recruited from attendees of the Hepatitis Carrier Clinic, Department of Medical Research (Lower Myanmar). Each subject was given 2,700 mg of FK-23 per day by oral route. Blood samples were taken at enrollment and every 3 months and tested for alanine aminotransferase (ALT) and aspartate transaminase (AST). Viral load, urea, total protein, hemoglobin and platelet count were determined every 6 months. Among the subjects, 23 completed 36 months, 31 completed 24 months, 35 completed 12 months and 37 completed 6 months of probiotic therapy. Significant decreases in mean ALT levels were observed at 3 months (34. 9 ± 15.1 IU/l) as compared with the initial level (64.8 ± 17.5 IU/l) and persisted up to 36 months (43.7 ± 25.2 IU/l). Decrease of AST was detected after 9 months (46.2 ± 21.7 IU/l) of probiotic therapy as compared with the initial level (64.3 ± 28.7 IU/l). FK-23 was safe based on the stable levels of biochemical and hematological parameters and the absence of untoward side effects. The FK-23 preparation was well tolerated and accepted by the subjects. A clinical trial was conducted on 39 adult HCV-positive subjects to determine the safety and long-term effect of the probiotic FK-23 (heat-treated Enterococcus faecalis strain FK-23). Asymptomatic anti-HCV positive adults who fulfilled the selection criteria and gave voluntary consent were recruited from attendees of the Hepatitis Carrier Clinic, Department of Medical Research (Lower Myanmar). Each subject was given 2,700 mg of FK-23 per day by oral route. Blood samples were taken at enrollment and every 3 months and tested for alanine aminotransferase (ALT) and aspartate transaminase (AST). Viral load, urea, total protein, hemoglobin and platelet count were determined every 6 months. Among the subjects, 23 completed 36 months, 31 completed 24 months, 35 completed 12 months and 37 completed 6 months of probiotic therapy. Significant decreases in mean ALT levels were observed at 3 months (34. 9 plus or minus 15.1 IU/l) as compared with the initial level (64.8 plus or minus 17.5 IU/l) and persisted up to 36 months (43.7 plus or minus 25.2 IU/l). Decrease of AST was detected after 9 months (46.2 plus or minus 21.7 IU/l) of probiotic therapy as compared with the initial level (64.3 plus or minus 28.7 IU/l). FK-23 was safe based on the stable levels of biochemical and hematological parameters and the absence of untoward side effects. The FK-23 preparation was well tolerated and accepted by the subjects. A clinical trial was conducted on 39 adult HCV-positive subjects to determine the safety and long-term effect of the probiotic FK-23 (heat-treated Enterococcus faecalis strain FK-23). Asymptomatic anti-HCV positive adults who fulfilled the selection criteria and gave voluntary consent were recruited from attendees of the Hepatitis Carrier Clinic, Department of Medical Research (Lower Myanmar). Each subject was given 2,700 mg of FK-23 per day by oral route. Blood samples were taken at enrollment and every 3 months and tested for alanine aminotransferase (ALT) and aspartate transaminase (AST). Viral load, urea, total protein, hemoglobin and platelet count were determined every 6 months. Among the subjects, 23 completed 36 months, 31 completed 24 months, 35 completed 12 months and 37 completed 6 months of probiotic therapy. Significant decreases in mean ALT levels were observed at 3 months (34. 9 ± 15.1 IU/l) as compared with the initial level (64.8 ± 17.5 IU/l) and persisted up to 36 months (43.7 ± 25.2 IU/l). Decrease of AST was detected after 9 months (46.2 ± 21.7 IU/l) of probiotic therapy as compared with the initial level (64.3 ± 28.7 IU/l). FK-23 was safe based on the stable levels of biochemical and hematological parameters and the absence of untoward side effects. The FK-23 preparation was well tolerated and accepted by the subjects. A clinical trial was conducted on 39 adult HCV-positive subjects to determine the safety and long-term effect of the probiotic FK-23 (heat-treated Enterococcus faecalis strain FK-23). Asymptomatic anti-HCV positive adults who fulfilled the selection criteria and gave voluntary consent were recruited from attendees of the Hepatitis Carrier Clinic, Department of Medical Research (Lower Myanmar). Each subject was given 2,700 mg of FK-23 per day by oral route. Blood samples were taken at enrollment and every 3 months and tested for alanine aminotransferase (ALT) and aspartate transaminase (AST). Viral load, urea, total protein, hemoglobin and platelet count were determined every 6 months. Among the subjects, 23 completed 36 months, 31 completed 24 months, 35 completed 12 months and 37 completed 6 months of probiotic therapy. Significant decreases in mean ALT levels were observed at 3 months (34. 9 ± 15.1 IU/l) as compared with the initial level (64.8 ± 17.5 IU/l) and persisted up to 36 months (43.7 ± 25.2 IU/l). Decrease of AST was detected after 9 months (46.2 ± 21.7 IU/l) of probiotic therapy as compared with the initial level (64.3 ± 28.7 IU/l). FK-23 was safe based on the stable levels of biochemical and hematological parameters and the absence of untoward side effects. The FK-23 preparation was well tolerated and accepted by the subjects. |
| Author | LWIN, Aye Aye TUN, Win Maw OO, Khin May KYAW, Yi Yi FUKADA, Kazutake GOSHIMA, Akiko SHIMADA, Takashi OKADA, Shigeru |
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| Cites_doi | 10.1155/2010/453563 10.1093/jac/47.5.709 10.1007/s00432-004-0550-2 10.1007/s00428-003-0943-7 10.1016/S0168-1605(98)00128-7 10.1097/00005176-199504000-00012 10.3748/wjg.v16.i4.403 10.1097/00001574-200403000-00017 10.1016/j.amjhyper.2005.06.006 10.3109/00365529709011206 10.1111/j.1365-2672.1989.tb05105.x 10.1016/0192-0561(94)90116-3 10.5812/hepatmon.7521 10.1017/S0007114514001792 10.3390/ijms11062499 |
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| Keywords | alanine aminotransferase (ALT) probiotic aspartate transaminase (AST) Enterococcus faecalis FK-23 |
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| References | 20. Maki N, Nohmi T, Shimada T, Yajin S, Yoda S, Ikeda H, Enomoto T. 2004. Efficacy of heat-treated Enterococcus faecalis FK-23 preparations on serum aminotransferase levels in patients with chronic type C hepatitis. Journal of the Japan Red Cross Society, Wakayama Medical Center 22: 19–24. 7. Salminen S, von Wright A, Morelli L, Marteau P, Brassart D, de Vos WM, Fondén R, Saxelin M, Collins K, Mogensen G, Birkeland SE, Mattila-Sandholm T. 1998. Demonstration of safety of probiotics—a review. Int J Food Microbiol 44: 93–106. 18. Nicole CL. 2010. Could probiotics help those with hepatitis C. Retrieved from http:www.hepatitiscentral.com/mHarchives/2010/12/. 22. Zafrani ES. 2004. Non-alcoholic fatty liver disease: an emerging pathological spectrum. Virchows Arch 444: 3–12. 14. Shimada T, Cheng L, Enomoto T, Yang X, Miyoshi A, Shirakawa T. 2004. Lysed Enterococcus faecalis FK-23 oral administration reveals inverse association between tuberculin response and clinical manifestations in perennial allergitis rhinitis: a pilot study. J Investig Allergol Clin Immunol 14: 187–192. 25. Shimada T, Cheng L, Shi HB, Hayashi A, Motonaga C, Tang J, Enomoto K, Enomoto T. 2007. Effect of lysed Enterococcus faecalis FK-23 on allergen-induced immune responses and intestinal microflora in antibiotic-treated weaning mice. J Investig Allergol Clin Immunol 17: 70–76. 11. Kato I, Endo K, Yokokura T. 1994. Effects of oral administration of Lactocbaccilus casei on anti-tumor responses induced by tumor resection in mice. Int J Immunopharmacol 16: 29–36. 13. Ooi LG, Liong MT. 2010. Cholesterol-lowering effects of probiotics and prebiotics: a review of in vivo and in vitro findings. Int J Mol Sci 11: 2499–2522. 21. Kondoh M, Shimada T, Fukada K, Morita M, Katada K, Higashimura Y, Mizushima K, Okamori M, Naito Y, Yoshikawa T. 2014. 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Chan CC, Hwang SJ, Lee FY, Wang SS, Chang FY, Li CP, Chu CJ, Lu RH, Lee SD. 1997. Prognostic value of plasma endotoxin levels in patients with cirrhosis. Scand J Gastroenterol 32: 942–946. 6. Fuller R. 1989. Probiotics in man and animals. J Appl Bacteriol 66: 365–378. 19. Imani Fooladi AA, Mahmoodzadeh Hosseini H, Nourani MR, Khani S, Alavian SM. 2013. Probiotic as a novel treatment strategy against liver disease. Hepat Mon 13: e7521. 8. Majamaa H, Isolauri E, Saxelin M, Vesikari T. 1995. Lactic acid bacteria in the treatment of acute rotavirus gastroenteritis. 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| References_xml | – reference: 22. Zafrani ES. 2004. Non-alcoholic fatty liver disease: an emerging pathological spectrum. Virchows Arch 444: 3–12. – reference: 18. Nicole CL. 2010. Could probiotics help those with hepatitis C. Retrieved from http:www.hepatitiscentral.com/mHarchives/2010/12/. – reference: 14. Shimada T, Cheng L, Enomoto T, Yang X, Miyoshi A, Shirakawa T. 2004. Lysed Enterococcus faecalis FK-23 oral administration reveals inverse association between tuberculin response and clinical manifestations in perennial allergitis rhinitis: a pilot study. J Investig Allergol Clin Immunol 14: 187–192. – reference: 23. Son G, Kremer M, Hines IN. 2010. Contribution of gut bacteria to liver pathobiology. Gastroenterol Res Pract 2010: 453563. – reference: 9. Fedorak RN, Madsen KL. 2004. Probiotics and prebiotics in gastrointestinal disorders. Curr Opin Gastroenterol 20: 146–155. – reference: 5. Huber CH, Wölfel T. 2004. Immunotherapy of cancer: from vision to standard clinical practice. J Cancer Res Clin Oncol 130: 367–374. – reference: 2. Kyi PK, Win KM, Aye M, Htwe YY, Oo KM, Aung T, Oo SS. 1998. Prevalence of hepatitis B and C infection in hepatocellular carcinoma cases in Myanmar. Myanmar Health Sci Res J 10: 1–5. – reference: 21. Kondoh M, Shimada T, Fukada K, Morita M, Katada K, Higashimura Y, Mizushima K, Okamori M, Naito Y, Yoshikawa T. 2014. Beneficial effects of heat-treated Enterococcus faecalis FK-23 on high-fat diet-induced hepatic steatosis in mice. Br J Nutr 112: 868–875. – reference: 11. Kato I, Endo K, Yokokura T. 1994. Effects of oral administration of Lactocbaccilus casei on anti-tumor responses induced by tumor resection in mice. Int J Immunopharmacol 16: 29–36. – reference: 16. Khin M, Swe TN. 2003. Contributions by the Japan International Cooperation Agency to hepatitis C control and research in Myanmar. DMR Bull 17: 1–17. – reference: 25. 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| Snippet | A clinical trial was conducted on 39 adult HCV-positive subjects to determine the safety and long-term effect of the probiotic FK-23 (heat-treated Enterococcus... A clinical trial was conducted on 39 adult HCV-positive subjects to determine the safety and long-term effect of the probiotic FK-23 (heat-treated Enterococcus... |
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| SubjectTerms | alanine aminotransferase (ALT) aspartate transaminase (AST) Enterococcus faecalis Enterococcus faecalis FK-23 Hepatitis C virus probiotic |
| Title | Safety and long-term effect of the probiotic FK-23 in patients with hepatitis C virus infection |
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