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.
ABSTRACT
A total of 280 apparently healthy volunteers were screened for hepatitis B (HB) markers out of which 49 subjects (17.5%) were positive for HB surface antigen (HBsAg) and 82 (29.3%) were positive for antibody to HBsAg (anti-HBs). Three doses of DMR-HB vaccine, 0.15 ml per dose were administered to 95 subjects, who were serologically negative for both HB markers. The vaccination was given by the intradermal route on the flexor surface of the left forearm, at 1 month intervals according to the 0, 1 and 2 months schedule. The subjects were carefully monitored to record any adverse reaction of the vaccine. Blood specimen was collected from each subject, 1 month after the second and third vaccinations, to determine the anti-HBs antibody response to the vaccine. The study results showed that local pain was the only side effect noted and protective antibodies (anti-HBs) were detected in 69 (72.6%) of the vaccinees after the second dose of the vaccine and 89 (93.6%) after the third dose of the vaccine. Thus the intradermal route, which would require approximately one-seventh of the standard dose, would be suitable for use in certain groups such as high risk adults, when the cost of the vaccine is the inhibiting factor for routine or mass vaccination.
