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Lactiplantibacillus plantarum SN13T 株およびイソマルトオリゴ糖が健常な20 歳以上日本人男女の便通および腸内環境に及ぼす影響―ランダム化プラセボ対照二重盲検並行群間比較試験―
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JPY
Abstract
Objective To examine the effects of consuming a beverage containing Lactiplantibacillus plantarum(formerly Lactobacillus plantarum)SN13T strain(SN13T)and isomaltooligosaccharides on bowel movement and intestinal environment of healthy Japanese adults who only defecate three to five times per week. Methods A total of 32 subjects were randomly assigned into two groups via a computer program in a 1:1 ratio. They were asked to drink one bottle(100 mL)of the test beverage or the placebo per day for two weeks. A bottle of the test beverage contained 1011 CFU SN13T and 1.8 g isomaltooligosaccharides. Assessment items were defecation frequency, defecation volume, stool form, the Japanese version of the constipation assessment scale, and immunoglobin A and microbiota levels in the stool. Furthermore, defecation frequency in periodⅣ(8-14 days of consumption)was set as the primary outcome. Results The efficacy analysis dataset was intended to treat defecation problems of 16 subjects for each group. The defecation frequency in periodⅣ was significantly higher in the test beverage group than that in the placebo group(P=0.042). Furthermore, the number of defecation days and the amount of defecation in periodⅣ and the fecal bacterial occupancy rate of Paraprevotella and Lactobacillus in the stool at 2 weeks postconsumption were higher in the test beverage group than in the placebo group. No adverse events were reported. Conclusions Consuming a beverage containing SN13T and isomaltooligosaccharides for two weeks improved the bowel movement and intestinal environment of the study subjects. Trial registration UMIN000046723 Foundation Nomura Dairy Products Co., Ltd. (Jpn Pharmacol Ther 2022;50:2053‒65)
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