薬理と治療

Abstract

Objective　The aim of the present study was to evaluate the effects of ingesting Bacillus subtilis C-3102 spores（C-3102）on human intestinal microbiota. Methods　A randomized placebo-controlled, double-blind study on 140 healthy Japanese subjects with constipation（defecation 2-4 times/week）was conducted. For 2 consecutive weeks, each subject ingested test tablets containing either C-3102 at a daily dose of 2.4×109 Colony Forming Unit（CFU）（C-3102 group）or placebo tablets without C-3102（placebo group）. The composition of fecal microbiota was measured using terminal restriction fragment length polymorphism（T-RFLP）analysis and quantitative PCR（qPCR）analysis. In addition, intestinal conditions such as frequency of defecation, stool quantity, and a refreshed feeling were monitored during the study. Results　T-RFLP analyses indicated that the relative abundance of Bifidobacterium in the C-3102 group was significantly higher than in the placebo group after ingestion of C-3102. Also, in subjects with initial numbers of Bifidobacterium less than 1010 CFU╱g, the C-3102 group had a tendency to have increased numbers of Bifidobacterium compared with the placebo group based on qPCR analysis. Defecation frequency significantly increased after ingestion of C-3102; however, the placebo group also showed a significant increase and there was no significant difference between the two groups. Stool quantity in the C-3102 group was significantly increased compared to the placebo group after 1 week of ingesting C-3102. Conclusions　These results show that C-3102 could increase Bifidobacterium levels and may improve intestinal function in subjects with constipation.