In a preliminary open-label trial by our group, Bifidobacterium bifidum YIT 10347 (YIT10347) relieved gastric symptoms in patients with functional gastrointestinal disorders. Hence, in this study, we investigated the effects of YIT10347 on gastrointestinal symptoms in healthy adults. In this prospective double-blind, randomized, placebo-controlled trial (UMIN000024654), 100 healthy Japanese adults were randomly assigned to a YIT10347 group or placebo group and consumed 100 mL of YIT10347-fermented milk or placebo fermented milk, respectively, every day for 4 wk. Gastrointestinal symptoms were evaluated by using the modified Frequency Scale for Symptoms of Gastroesophageal Reflux Disease (m-FSSG) and Gastrointestinal Symptom Rating Scale (GSRS) as primary endpoints. Mental symptoms, quality of life, salivary stress markers, and gastric emptying were evaluated as secondary endpoints. Effectiveness and safety were analyzed in a per-protocol set (YIT10347 group, n = 39; placebo group, n = 40) and full analysis set (YIT10347 group, n = 50; placebo group, n = 50), respectively. In the m-FSSG evaluation, the YIT10347 group had a significantly higher relief rate of postprandial discomfort and greater changes in postprandial epigastric pain score from baseline than the placebo group. In the GSRS evaluation, the YIT10347 group had significantly higher relief rates of overall gastrointestinal symptoms, upper gastrointestinal symptoms, flatus, and diarrhea than the placebo group. We detected no significant differences in scores or relief rates of mental symptoms and quality of life, a salivary stress marker, or gastric emptying between the 2 groups. No severe adverse events associated with test beverage consumption were observed in either group. These findings suggest that daily consumption of YIT10347-fermented milk exerts beneficial effects on gastrointestinal discomfort and symptoms such as postprandial discomfort and epigastric pain in healthy adults.

在我们小组进行的初步开放标签试验中，双歧杆菌YIT 10347（YIT10347）缓解了功能性胃肠道疾病患者的胃部症状。因此，在这项研究中，我们调查了YIT10347对健康成年人胃肠道症状的影响。在这项前瞻性双盲，随机，安慰剂对照试验（UMIN000024654）中，将100名健康的日本成年人随机分配到YIT10347组或安慰剂组中，并分别饮用100 mL YIT10347发酵乳或安慰剂发酵乳。 4周。胃肠道症状的评估采用改良的胃食管反流病症状频率表（m-FSSG）和胃肠道症状评定量表（GSRS）作为主要终点。精神症状，生活质量，唾液压力指标和胃排空被评估为次要终点。分别在每个方案组（YIT10347组，n = 39；安慰剂组，n = 40）和完整分析组（YIT10347组，n = 50；安慰剂组，n = 50）中分析了有效性和安全性。在m-FSSG评估中，与安慰剂组相比，YIT10347组的餐后不适缓解率显着更高，餐后上腹痛评分的变化较基线大。在GSRS评估中，YIT10347组的总体胃肠道症状，上消化道症状，肠胃气和腹泻的缓解率明显高于安慰剂组。在两组之间，我们在精神症状和生活质量，唾液压力指标或胃排空方面的得分或缓解率没有显着差异。两组均未观察到与测试饮料消费相关的严重不良事件。这些发现表明，每天摄入YIT10347发酵乳对健康成年人的胃肠道不适和餐后不适和上腹部疼痛等症状具有有益的作用。