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.