Heat-killed Bifidobacterium longum CLA8013 has been demonstrated to improve the frequency of defecation, straining, and pain during defecation in human placebo-controlled, double-blind, parallel-group studies. We cond...Heat-killed Bifidobacterium longum CLA8013 has been demonstrated to improve the frequency of defecation, straining, and pain during defecation in human placebo-controlled, double-blind, parallel-group studies. We conducted a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety of both long-term and excessive intakes of heat-killed B. longum CLA8013, when used as a food with functional claims. In both tests, 30 healthy volunteers were divided into two groups: an active group that ingested heat-killed B. longum CLA8013 and a placebo group. In the long-term intake safety study, participants in the active group ingested 25 billion cells/day for 12 weeks. In the excessive intake safety study, participants in the active group ingested 125 billion cells/day for 4 weeks. Physical, hematological, biochemical, and urine examinations were conducted, and adverse events were evaluated in both studies. The studies revealed no abnormalities in any of the safety tests. In conclusion, no safety-related issues were identified with long-term or excessive intake of heat-killed B. longum CLA8013.展开更多
Background/Aims: Administration of a lactic acid bacterial strain, Lactococcus lactis subsp. lactis JCM 5805 (LC-Plasma), is reported to prevent viral infection via activation of plasmacytoid dendritic cells in mouse ...Background/Aims: Administration of a lactic acid bacterial strain, Lactococcus lactis subsp. lactis JCM 5805 (LC-Plasma), is reported to prevent viral infection via activation of plasmacytoid dendritic cells in mouse and human studies. As it is assumed that LC-Plasma is taken in excess when it is commercially provided as a supplement, we conducted a trial using capsules to give 250 mg LC-Plasma (5 times the effective anti-viral dose) every day for four weeks to healthy volunteers to investigate the safety of excessive intake of LC-Plasma. Trial Design: A randomized, double-blind, placebo-controlled, parallel-group trial was conducted. Methods: Forty healthy subjects were randomly assigned to the LC-Plasma group (daily intake of five capsules containing 50 mg heat-killed LC-Plasma cells per capsule) or the placebo group (daily intake of five placebo capsules with no LC-Plasma). Physical, hematological, biochemical and urinary examinations and medical interviews were used to evaluate safety. Results: No abnormal differences were observed after excessive intake of LC-Plasma capsules when compared to the intake of placebo capsules. Conclusions: There are no safety concerns associated with the excessive intake of heat-killed LC-Plasma capsules.展开更多
文摘Heat-killed Bifidobacterium longum CLA8013 has been demonstrated to improve the frequency of defecation, straining, and pain during defecation in human placebo-controlled, double-blind, parallel-group studies. We conducted a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety of both long-term and excessive intakes of heat-killed B. longum CLA8013, when used as a food with functional claims. In both tests, 30 healthy volunteers were divided into two groups: an active group that ingested heat-killed B. longum CLA8013 and a placebo group. In the long-term intake safety study, participants in the active group ingested 25 billion cells/day for 12 weeks. In the excessive intake safety study, participants in the active group ingested 125 billion cells/day for 4 weeks. Physical, hematological, biochemical, and urine examinations were conducted, and adverse events were evaluated in both studies. The studies revealed no abnormalities in any of the safety tests. In conclusion, no safety-related issues were identified with long-term or excessive intake of heat-killed B. longum CLA8013.
文摘Background/Aims: Administration of a lactic acid bacterial strain, Lactococcus lactis subsp. lactis JCM 5805 (LC-Plasma), is reported to prevent viral infection via activation of plasmacytoid dendritic cells in mouse and human studies. As it is assumed that LC-Plasma is taken in excess when it is commercially provided as a supplement, we conducted a trial using capsules to give 250 mg LC-Plasma (5 times the effective anti-viral dose) every day for four weeks to healthy volunteers to investigate the safety of excessive intake of LC-Plasma. Trial Design: A randomized, double-blind, placebo-controlled, parallel-group trial was conducted. Methods: Forty healthy subjects were randomly assigned to the LC-Plasma group (daily intake of five capsules containing 50 mg heat-killed LC-Plasma cells per capsule) or the placebo group (daily intake of five placebo capsules with no LC-Plasma). Physical, hematological, biochemical and urinary examinations and medical interviews were used to evaluate safety. Results: No abnormal differences were observed after excessive intake of LC-Plasma capsules when compared to the intake of placebo capsules. Conclusions: There are no safety concerns associated with the excessive intake of heat-killed LC-Plasma capsules.
