薬理と治療

Abstract

Objective　To investigate the effects of consumption of beverages containing rice bran fermented products on bowel movement and intestinal environment in healthy Japanese adults who defecate three to five times per week. Methods　A total of 34 participants were randomly stratified into two groups at a 1:1 ratio using a computer program. They were asked to drink one pack each before breakfast and dinner( two packs per day)of the test beverage or placebo for 2 weeks. A bottle of the test beverage contained 1.1×108 CFU Lactobacillus paracasei TLPT, 8.8×107 CFU Saccharomyces cerevisiae TSCT and 4.9×106 CFU Pichia membranifaciens TPMT. Assessment items included defecation frequency, number of defecations, defecation volume, stool form, stool smell, satis-faction after defecation and the Japanese version of the constipation assessment scale. Defecation frequency in period Ⅲ(8–14 days of consumption)was the primary outcome. Results　The efficacy analysis dataset was the intention to treat, and 17 participants were included in each group. The defecation frequency(Placebo group 5.0±2.0 times, Test beverage group 6.6±2.2 times, P=0.007)and number of defecations(Placebo group 4.4±1.4 days, Test beverage group 5.4±1.4 days, P=0.042)in period Ⅲ were significantly higher in the Test beverage group than in the Placebo group. No adverse events were reported. Conclusions　Consuming a beverage containing LBS symbiotic fungus for 2 weeks enhanced bowel movement of healthy Japanese adults who defecate three to five times per week. Trial registration　UMIN000047765 Foundation　Litanial Bio Science. Co., Ltd. (Jpn Pharmacol Ther 2024;52:819‒31)