title: Safety and long-term effect of the probiotic FK-23 in patients with hepatitis C virus infection.
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.
authors: Department of Medical Research (Lower Myanmar), No. 5 Ziwaka Road, 11191 Yangon, Republic of the Union of Myanmar.
authors: Khin May
authors: KM
authors: Oo
authors: Department of Medical Research (Lower Myanmar), No. 5 Ziwaka Road, 11191 Yangon, Republic of the Union of Myanmar.
authors: Aye Aye
authors: AA
authors: Lwin
authors: Department of Medical Research (Lower Myanmar), No. 5 Ziwaka Road, 11191 Yangon, Republic of the Union of Myanmar.
authors: Yi Yi
authors: YY
authors: Kyaw
authors: Department of Medical Research (Lower Myanmar), No. 5 Ziwaka Road, 11191 Yangon, Republic of the Union of Myanmar.
authors: Win Maw
authors: WM
authors: Tun
authors: Central Research Laboratories, Nichinichi Pharmaceutical Corporation Ltd., 239-1 Tominaga, Iga City, Mie 518-1417, Japan.
authors: Kazutake
authors: K
authors: Fukada
authors: Central Research Laboratories, Nichinichi Pharmaceutical Corporation Ltd., 239-1 Tominaga, Iga City, Mie 518-1417, Japan.
authors: Akiko
authors: A
authors: Goshima
authors: Central Research Laboratories, Nichinichi Pharmaceutical Corporation Ltd., 239-1 Tominaga, Iga City, Mie 518-1417, Japan; Department of Gastrointestinal Immunology, Kyoto Prefectural University of Medicine, Kamigyo-ku, Kyoto 602-8566, Japan.
authors: Takashi
authors: T
authors: Shimada
authors: Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, 2-6-7 Bancho, Kita-ku, Okayama 700-0811, Japan.
authors: Shigeru
authors: S
authors: Okada
keywords: Enterococcus faecalis FK-23; alanine aminotransferase (ALT); aspartate transaminase (AST); probiotic