Safety and long-term effect of the probiotic FK-23 in patients with hepatitis C virus infection

Khin May OO; Aye Aye LWIN; Yi Yi KYAW; Win Maw TUN; Kazutake FUKADA; Akiko GOSHIMA; Takashi SHIMADA; Shigeru OKADA

doi:10.12938/bmfh.2015-024

Full Paper

Safety and long-term effect of the probiotic FK-23 in patients with hepatitis C virus infection

Khin May OO, Aye Aye LWIN, Yi Yi KYAW, Win Maw TUN, Kazutake FUKADA, Akiko GOSHIMA, Takashi SHIMADA, Shigeru OKADA

Author information

Khin May OO
Department of Medical Research (Lower Myanmar), No. 5 Ziwaka Road, 11191 Yangon, Republic of the Union of Myanmar
Aye Aye LWIN
Department of Medical Research (Lower Myanmar), No. 5 Ziwaka Road, 11191 Yangon, Republic of the Union of Myanmar
Yi Yi KYAW
Department of Medical Research (Lower Myanmar), No. 5 Ziwaka Road, 11191 Yangon, Republic of the Union of Myanmar
Win Maw TUN
Department of Medical Research (Lower Myanmar), No. 5 Ziwaka Road, 11191 Yangon, Republic of the Union of Myanmar
Kazutake FUKADA
Central Research Laboratories, Nichinichi Pharmaceutical Corporation Ltd., Mie 518-1417, Japan
Akiko GOSHIMA
Central Research Laboratories, Nichinichi Pharmaceutical Corporation Ltd., Mie 518-1417, Japan
Takashi SHIMADA
Central Research Laboratories, Nichinichi Pharmaceutical Corporation Ltd., Mie 518-1417, Japan
Department of Gastrointestinal Immunology, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan
Shigeru OKADA
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama 700-0811, Japan

Keywords: probiotic, alanine aminotransferase (ALT), aspartate transaminase (AST), Enterococcus faecalis FK-23

JOURNAL FREE ACCESS

2016 Volume 35 Issue 3 Pages 123-128

DOI https://doi.org/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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