Effects of heat-killed Lactobacillus casei subsp. casei 327 intake on defecation in healthy volunteers: a randomized, double-blind, placebo-controlled, parallel-group study

Abstract

Lactobacillus casei subsp. casei 327 (L. casei 327) was isolated from brown rice. A preliminary study showed that intake of 50 mg of heat-killed L. casei 327 is effective in improving defecation. In this study, we conducted a randomized, double-blind, placebo-controlled, parallel-group trial to investigate the effect of intake of heat-killed L. casei 327 (25 mg: approximately 5 × 1010 bacteria) on defecation in healthy volunteers with relatively low defecation frequencies. We selected 104 healthy Japanese adults with relatively low defecation frequencies (approximately 3-5 times a week) by screening and pretrial tests. Subjects (n=52 in each group) were randomly given a tablet containing L. casei 327 (group A) or a placebo tablet (group P) daily for 2 weeks. After eliminating data for 9 subjects who met the exclusion criteria for efficacy analysis, data for 95 subjects were analyzed. The defecation frequency and number of defecation days during the intake period and their changes from the pretrial period were significantly higher in group A than in group P. The fecal volume during the intake period was higher in group A than group P, but the difference was not statistically significant. However, the change from the pretrial period was significantly higher in group A than in group P. There were no significant differences between groups in the values of fecal shape, color, odor, and feeling after defecation. These results suggested that intake of L. casei 327 improves defecation in healthy adults who have relatively low defecation frequencies.

Keywords: Lactobacillus casei; clinical study; defecation; healthy volunteers; lactic acid bacteria.