Data from: A randomized synbiotic trial to prevent sepsis among infants in rural India

Sepsis in early infancy results in one million annual deaths worldwide, most of them in developing countries. No efficient means of prevention is currently available. Here we report on a randomized, double-blind, placebo-controlled trial of an oral synbiotic preparation (Lactobacillus plantarum plus fructooligosaccharide) in rural Indian newborns. We enrolled 4,556 infants that were at least 2,000 g at birth, at least 35 weeks of gestation, and with no signs of sepsis or other morbidity, and monitored them for 60 days. We show a significant reduction in the primary outcome (combination of sepsis and death) in the treatment arm (risk ratio 0.60, 95% confidence interval 0.48–0.74), with few deaths (4 placebo, 6 synbiotic). Significant reductions were also observed for culture-positive and culture-negative sepsis and lower respiratory tract infections. These findings suggest that a large proportion of neonatal sepsis in developing countries could be effectively prevented using a synbiotic containing L. plantarum ATCC-202195.婴儿早期脓毒症每年在全球造成100万例死亡，其中绝大多数发生在发展中国家，目前尚无有效的预防手段。本研究针对印度农村地区新生儿开展了一项口服合生制剂（synbiotic，由植物乳杆菌（Lactobacillus plantarum）与低聚果糖（fructooligosaccharide）组成）的随机双盲安慰剂对照试验，共纳入4556名新生儿，纳入标准为出生体重≥2000克、胎龄≥35周，无脓毒症或其他疾病征象，并对所有受试者进行为期60天的随访监测。研究结果显示，治疗组（treatment arm）的主要结局指标（脓毒症与死亡的复合终点）显著降低，风险比（risk ratio）为0.60，95%置信区间（confidence interval）为0.48~0.74；两组死亡例数极少，安慰剂组4例，合生制剂组6例。培养阳性脓毒症、培养阴性脓毒症以及下呼吸道感染的发生率也均观察到显著下降。上述研究结果表明，对于发展中国家的大部分新生儿脓毒症病例，使用含有植物乳杆菌ATCC-202195的合生制剂可实现有效预防。