薬理と治療

Abstract

Background Health benefits of Bacillus coagulans SANK 70258, spore-forming lactic acid bacteria, has been claimed. Preliminary results suggest its benefit on bowel movement. Objective To confirm bowel movement-promoting effect of B. coagulans in a randomized, double-blind, placebo-controlled, parallel-group study.Methods/study design Volunteers（n＝60）whose stool frequency was relatively lower were enrolled. Subjects were randomly allocated to B. coagulans-containing food group（group A, n＝30）or placebo group（group P, n＝30）. Stool frequency, stool properties, amount of defecation, and pattern of intestinal flora populations were investigated in the pre-observation period and during the investigational food intake period of 2 weeks, and changes from the pre-observation period values were analyzed. Results The changes in stool frequency between the two periods in the per protocol population（n＝58）were 3.0±3.0 and 1.6±2.9 times╱2 weeks in groups A and P, respectively（P＝0.09）. The intergroup difference was significant in the population（n＝53）after excluding subjects who took an antibiotic or experienced a change in eating habit（3.0±3.0 and 1.2±2.8 times╱2 weeks in groups A and P, respectively, P＝0.03）. No significant intergroup differences were found in the changes in stool properties, defecation amount, and intestinal flora pattern. No serious adverse event related to the active food intake was observed. Conclusion Benefit of B. coagulans intake on bowel movement is suggested.