薬理と治療

Abstract

Objectives Lactobacillus brevis SBC8803（SBL88TM）is speculated to enhance the quality of sleep（QOS）. Hence, this study aims to investigate QOS following the 4-week SBL88TM intake. Methods In this randomized, double-blind, parallel-group, placebo-controlled study, we enrolled healthy Japanese subjects（n＝220）who reported QOS dissatisfaction. Subjects were randomly assigned into either the intervention or placebo group（n＝110 each）using a computerized random-number generator. Each group ingested either one SBL88TM tablet or placebo tablet per day at the optional timing for 4 weeks. Outcomes were evaluated using the OSA sleep inventory MA version（OSA-MA）and sleep scanning mat device. Furthermore, the safety was evaluated. Results The per protocol set comprised 103 subjects（103 subjects for sleep test data）in the intervention group and 101 subjects（99 subjects for sleep test data）in the placebo group. In the intervention group, factor I（sleepiness on rising）and factor IV（refreshing）scores in the OSA-MA, the primary outcomes, significantly improved（P＜0.05）. Sleep efficiency and occurrence of the rapid eye movement（REM）significantly increased, and the appearance of awaking significantly decreased（P＜0.05）. Moreover, rate of deep sleep significantly suppressed the decrease in the first half of sleep but increased in the second half（P＜0.05）. Furthermore, no adverse effects were observed. Conclusions Our results suggest that SBL88TM intake improves QOS. Furthermore, SBL88TM intake was safe under the conditions of this study. Trial registration UMIN︱CTR: UMIN000029210 Foundation SAPPORO HOLDINGS LTD.