薬理と治療

Abstract

Objective Ingestion of Bacillus subtilis C-3102 is expected to regulate the intestinal environment. We evaluated the safety of long-term administration of B. subtilis C-3102-containing food in a randomized, double-blind, placebo-controlled, parallel-group study. Methods Forty healthy Japanese subjects were randomly allocated into either C-3102 group or placebo group（20 subjects each）. The subjects took either B. subtilis C-3102（4.0⊠109 cfu╱day）or placebo food, with water, after breakfast for 12 weeks. The safety evaluation included physical examination, urinalysis, blood analysis, a questionnaire, diary of bowel movement, and a medical questionnaire by the physician. Results Three subjects（two from the C-3102 group and one from the placebo group）were lost to follow-up and excluded from the analysis. Of the 37 subjects included in the analysis, 18 were from the C-3102 group（9 male, 9 female, mean age and standard deviation［SD］of48.9±14.7 years）, and 19 subjects were from the placebo group（10 male, 9 female, mean age and SD of 48.5±12.0 years）. No safety concerns were observed during the intervention period. Conclusions The present study demonstrated that long-term administration of B. subtilis C-3102-containing food in healthy subjects was safe under the conditions of the study. Trial registration UMIN-CTR: UMIN000028195