薬理と治療

Abstract

Objective　We assessed heat treatment Enterococcus faecalis strain KH2 in terms of safety and efficacy for increasing amount of defecation in a randomized placebo controlled double-blind paralleled study. Methods　This study included a total of 30 healthy Japanese adult volunteers 30-59 aged years who were selected by defecation frequency two to five times a week. Subjects were randomly assigned to two groups（KH2 group or placebo group）. Subjects consumed powder preparation containing of 100 mg KH2 and 900 mg dextrin mixture or 1000 mg dextrin daily for 1 week. Intestinal microflora was assessed using terminal restriction fragment length polymorphism analysis（T-RFLP）at baseline and one week after the start of administration KH2 or placebo. Results　A total of 25 subjects（KH2 group, n＝10；placebo group, n＝15）completed the study. At one week after the start of the test-food consumption, the primary endpoint, amount of defecation which was evaluated by using Japanese version of constipation assessment scale （CAS-MT）, was significantly high in KH2 group（P＝0.01）. The secondary endpoint, the change amount of occupying rate of Clostridium cluster Ⅳ in intestinal microflora was also significantly high in KH2 group（P＝0.003）. Safety parameters and incidence of adverse events did not differ significantly between two groups. Conclusion　These results indicate that promoting defecation by ingestion of KH2 and improving the intestinal environment. Conclusion　These results indicate that promoting defecation by ingestion of KH2 and improving the intestinal environment.