薬理と治療

Abstract

Objective This study investigated the effects of foods containing resistant dextrin and galactooligosaccharide on the intestinal environment in healthy Japanese adults who defecated 2-5 times per week. Method This was a randomized, double-blind, placebo-controlled, parallel-group trial. Forty-four healthy Japanese adult subjects with a lower Bifidobacterium ratio in their intestinal flora and lower defecation frequency were selected by a physician. Subjects were assigned to either an active or placebo group using a computerized random number generator and consumed the appropriate test foods for two weeks. As the primary outcome, intestinal flora was analyzed using terminal restriction fragment length polymorphism（T-RFLP）. Subjective symptoms, stool form, and defecation frequency were evaluated using the Constipation Assessment Scale-middle term（CAS-MT）, stool form scale, and a diary, respectively. All outcomes were evaluated each week. A safety evaluation was also performed. Results The outcomes in the active（n＝22）and placebo（n＝21）groups were analyzed. In the active group, the Bifidobacterium ratio increased significantly compared with that in the placebo group at 1 and 2 weeks. In addition, the total CAS-MT scores decreased significantly and defecations per day increased significantly in the active group compared with the placebo group at 2 weeks. There were no adverse effects. Conclusions Consumption of foods containing resistant dextrin and galactooligosaccharide significantly improved the intestinal environment and promoted defecation by increasing the occupation ratio of Bifidobacterium in healthy Japanese adults who defecated 2-5 times per week. Trial registration UMIN-CTR: UMIN000022760 Funding Aishitoto Co., Ltd