薬理と治療

Abstract

Objectives　This study aimed to evaluate the effect of colon-targeted capsules containing Bifidobacterium longum BB536 on defecation frequency, stool consistency and Quality of Life using the randomized, double-blind, placebo-controlled, parallel-group comparative method. Methods　Sixty healthy volunteers （age 20-65 y）with a tendency for constipation or loose stool were randomly divided into test（n＝30）and placebo groups（n＝30）. Groups received a colon-targeted capsule containing Bifidobacterium longum BB536（more than 5.0⊠109 cfu） or a placebo daily for 4 weeks. The bowel habits were recorded each day for 2 weeks before the intake period and 4 weeks during the intake period. Gastrointestinal Symptom Rating Scale （GSRS）and 36-item Short Form Survey（SF-36）were measured at day before the intake period and 14th day and 28th day of the intake period. Results　All 60 participants completed the study, with no adverse events related to colon-targeted capsules. Seven participants were excluded before efficacy analysis because of conflict with exclude criteria; the 53 participants were analyzed. Defecation frequency, stool consistency and GSRS did not differ significantly between test and placebo groups. In the SF-36, mental health score and change in social function score of the test group were significantly higher than that of the placebo group after intake period. In participants with a tendency for loose stool, stool consistency andʻloose stoolʼscore of the test group significantly improved compared to that of the placebo group after intake period. Conclusions　Colon-targeted capsules containing Bifidobacterium longum BB536 were shown to have effects of improving the loose stool and health︱related Quality of Life. （UMIN000034463）