薬理と治療

Abstract

Objectives　To evaluate the effects of Lactobacillus paragasseri SBT 2055（LG 2055）on improving defecation. Methods　A randomized, double–blind, placebo–controlled, parallel–group comparative study was conducted in 80 healthy adult male and female subjects with tendency to constipation. The subjects were randomly allocated to one of the two groups that ingested either capsules containing LG2055（≥1×109 cfu/day）or placebo capsules for 4 weeks. The primary endpoint was defecation frequency and other evaluation items were defecation survey, the number of viable lactobacilli in feces, analysis of gut microbiota, metabolites in feces, and subjective symptoms of constipation（JPAC–QOL）. Results　Thirty six subjects in each groups were analyzed, respectively. Defecation frequency of LG2055 group tended to increase compared to the placebo group（P＝0.087）. Stratified analysis excluding subjects with high fecal lactobacilli counts at beginning, showed a significant increase in the defecation frequency in LG2055 group compared to placebo group. In addition, significant increases in the viable number of lactobacilli, lactic acid concentration and the ratio of Agathobacter, as well as a significant decrease in the ratio of Desulfovibrio were observed in the LG2055 group, suggesting an improvement on the intestinal environment. Conclusions　It was suggested that continuous intake of LG2055 for 4 weeks improved the intestinal environment and contributed to the improvement of defecation. Trial registration　UMIN000048911 Foundation　Megmilk Snow Brand Co., Ltd.（Jpn Pharmacol Ther 2023；51：1365‒76）