Multicenter Trial of a Combination Probiotic for Children with Gastroenteritis
Multicenter Trial of a Combination Probiotic for Children with Gastroenteritis
复制标题
DOI：
10.1056/nejmoa1802597
复制
发表时间：
2018-11-22
影响因子：
158.5
通讯作者：
Schuh, Suzanne
中科院分区：
文献类型：
--
作者：
Freedman, Stephen B.;Williamson-Urquhart, Sarah;Schuh, Suzanne
背景：在美国，每年约有170万儿童因星状肠炎就诊。目前还缺乏确定使用益生菌是否能改善这些儿童预后的数据。方法我们进行了一项随机双盲试验，涉及886名3至48个月大的胃肠炎儿童，他们在加拿大的6个儿科医院就诊。参与者接受为期5天的联合益生菌产品治疗，其中含有鼠李糖乳杆菌R0011和L. helveticus R0052，剂量为4 × 10(9)菌落形成单位，每天两次或安慰剂。主要结局为中度至重度胃肠炎，根据入组后改良的Vesikari量表症状评分为9分或更高（评分范围从0到20分，得分越高表明疾病越严重）来定义。次要结局包括腹泻和呕吐的持续时间，未安排医生就诊的儿童比例，以及不良事件的存在与否。结果：414名益生菌组参与者中有108人（261%）在入组后14天内发生了中重度胃肠炎，413名安慰剂组参与者中有102人（24.7%）发生了中重度胃肠炎(优势比为1.06；95%可信区间（CI）为0.77 ~ 1.46；P = 0.72)。在调整了试验地点、年龄、粪便中轮状病毒的检测以及入组前腹泻和呕吐的频率后，试验组分配不能预测中度至重度胃肠炎（优势比1.06;95% CI 0.76 ~ 1.49； P=0.74）。益生菌组和安慰剂组的中位腹泻持续时间分别为52.5小时（18.3至95.8）和55.5小时（20.2至102.3），差异无统计学意义；P=0.31)或呕吐(17.7小时（四分位数范围，0至58.6）和18.7小时（四分位数范围，0至51.6），非计划访问医疗保健提供者的参与者百分比（30.2%和26.6%；优势比，1.19;95% CI， 0.87至1.62；P=0.27），以及报告不良事件的参与者百分比（34.8%和38.7%；优势比，0.83;95% CI， 0.62至1.11；P=0.21）。结论：在因胃肠炎就诊的儿童中，每日两次联合给予鼠李糖- l。在入组后14天内，Helveticus益生菌并没有阻止中重度胃肠炎的发生。
BACKGROUNDGastroenteritis accounts for approximately 1.7 million visits to the emergency department (ED) by children in the United States every year. Data to determine whether the use of probiotics improves outcomes in these children are lacking.METHODSWe conducted a randomized, double-blind trial involving 886 children 3 to 48 months of age with gastroenteritis who presented to six pediatric Ells in Canada. Participants received a 5-day course of a combination probiotic product containing Lactobacillus rhamnosus R0011 and L. helveticus R0052, at a dose of 4.0x10(9) colony-forming units twice daily or placebo. The primary outcome was moderate-to-severe gastroenteritis, which was defined according to a post-enrollment modified Vesikari scale symptom score of 9 or higher (scores range from 0 to 20, with higher scores indicating more severe disease). Secondary outcomes included the duration of diarrhea and vomiting, the percentage of children who had unscheduled physician visits, and the presence or absence of adverse events.RESULTSModerate-to-severe gastroenteritis within 14 days after enrollment occurred in 108 of 414 participants (261%) who were assigned to probiotics and 102 of 413 participants (24.7%) who were assigned to placebo (odds ratio, 1.06; 95% confidence interval (CI), 0.77 to 1.46; P=0.72). After adjustment for trial site, age, detection of rotavirus in stool, and frequency of diarrhea and vomiting before enrollment, trial-group assignment did not predict moderate-to-severe gastroenteritis (odds ratio, 1.06; 95% CI, 0.76 to 1.49; P=0.74). There were no significant differences between the probiotic group and the placebo group in the median duration of diarrhea (52.5 hours (interquartile range, 18.3 to 95.8) and 55.5 hours (interquartile range, 20.2 to 102.3), respectively; P=0.31) or vomiting (17.7 hours (interquartile range, 0 to 58.6] and 18.7 hours (interquartile range, 0 to 51.6], P=0.18), the percentages of participants with unscheduled visits to a health care provider (30.2% and 26.6%; odds ratio, 1.19; 95% CI, 0.87 to 1.62; P=0.27), and the percentage of participants who reported an adverse event (34.8% and 38.7%; odds ratio, 0.83; 95% CI, 0.62 to 1.11; P=0.21).CONCLUSIONSIn children who presented to the emergency department with gastroenteritis, twice-daily administration of a combined L. rhamnosus-L. helveticus probiotic did not prevent the development of moderate-to-severe gastroenteritis within 14 days after enrollment.