薬理と治療

Abstract

Objective　This study aimed to verify the effects of consuming 1–g galactooligosaccharide per day on gut microbiota, particularly Bifidobacterium, in healthy Japanese adults. Methods　In this randomized, double–blind, placebo–controlled, parallel–group comparison study, 56 participants were randomly divided into two groups（active group and placebo group）, and were instructed to take one packet of test food per day for 3 weeks. The packets received by the active group contained 1–g galactooligosaccharide, while the packets received by the placebo group lacked galactooligosaccharides. The evaluation parameters included the count of Bifidobacterium genus determined by real–time PCR in the stool. Results　A total of 56 participants met the inclusion criteria, and were randomized to either the active（n＝28）or placebo group（n＝28）. The analysis dataset was full analysis set, and included 26 participants in each group. Two participants from each group were excluded for non–compliance. After 3 weeks, the logarithm count of the Bifidobacterium genus in the active group was significantly higher than the placebo group. Additionally, adverse events due to test foods were not observed. Conclusions　Consuming 1–g galactooligosaccharide per day can help maintain healthy gut microbiota by increasing the concentration of Bifidobacterium. Trial registration　UMIN000049636 Foundation　Nissin Sugar Co., Ltd.（Jpn Pharmacol Ther 2024；52：19‒29）