Yakult Central Institute, 5-11 Izumi, Kunitachi-shi, Tokyo 186-8650, Japan.
Yakult Central Institute, 5-11 Izumi, Kunitachi-shi, Tokyo 186-8650, Japan.
J Dairy Sci. 2018 Jun;101(6):4830-4841. doi: 10.3168/jds.2017-13803. Epub 2018 Mar 21.
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.
在我们小组进行的一项初步开放性试验中,双歧杆菌 YIT 10347(YIT10347)缓解了功能性胃肠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,100 名健康的日本成年人被随机分配到 YIT10347 组或安慰剂组,每天分别饮用 100 毫升 YIT10347 发酵乳或安慰剂发酵乳,持续 4 周。胃肠道症状通过改良的胃食管反流病症状频率量表(m-FSSG)和胃肠道症状评分量表(GSRS)进行评估,作为主要终点。精神症状、生活质量、唾液应激标志物和胃排空作为次要终点进行评估。在方案设定(YIT10347 组,n=39;安慰剂组,n=40)和全分析集(YIT10347 组,n=50;安慰剂组,n=50)中分别进行有效性和安全性分析。在 m-FSSG 评估中,YIT10347 组餐后不适缓解率和餐后上腹痛评分较基线的变化显著高于安慰剂组。在 GSRS 评估中,YIT10347 组整体胃肠道症状、上胃肠道症状、呃逆和腹泻的缓解率均显著高于安慰剂组。两组间精神症状和生活质量、唾液应激标志物或胃排空的评分或缓解率无显著差异。两组均未观察到与测试饮料摄入相关的严重不良事件。这些发现表明,每天饮用 YIT10347 发酵乳对健康成年人的胃肠道不适和症状(如餐后不适和上腹痛)具有有益作用。
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