薬理と治療

Abstract

Objective　This study determined the effects of the T-1 lactic acid bacteria（T-1LAB: Streptococcus thermophilus AK and Lactobacillus delbrueckii subsp. bulgaricus KD）on the bowel movements of healthy Japanese adults with mild constipation. Methods　This study was a randomized, placebo-controlled, double-blind, parallel-group study conducted on healthy Japanese subjects（n＝44）who defecated three to five times a week. Subjects were randomly allocated into two groups（n＝22 in each group）. The T-1LAB group consumed a soy milk product fermented with T-1LAB. The Placebo group consumed a soy milk product containing lactic acid and gelatin but without T-1LAB; the subjects consumed 100 g of the assigned products daily for two weeks. The primary outcome was defecation frequency per week. The secondary outcomes were the number of days and the amount of defecation in a week, shape of stool, subjective symptoms for constipation, the Bristol Stool Scale, profile of gut microbiota, total number of bifidobacteria, fecal analysis data（pH, water content, organic acids, putrefactive products, and bile acids）, facial skin assessment, skin moisture, and transepidermal water loss. Results　In each group, 21 subjects were finally analyzed for efficacy. In the T-1LAB group, the defecation frequency and the number of days of defecation in a week were significantly increased, and skin pigmentation and crowʼs feet were significantly improved compared with the Placebo group（P＜0.05）. There were no adverse events related to the test products. Conclusions　These results suggest that T-1LAB consumption may improve bowel movements in healthy Japanese subjects with mild constipation. Trial registration　UMIN-CTR: UMIN000038362 Foundation　KIKKOMAN SOYFOODS COMPANY.