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

Pinaki Panigrahi, Sailajanandan Parida, Nimai C. Nanda, Radhanath Satpathy, Lingaraj Pradhan, DInesh S. Chandel, Lorena Baccaglini, Arjit Mohapatra, Subhranshu S. Mohapatra, Pravas R. Misra, Rama Chaudhry, Hegang H. Chen, Judith A. Johnson, J. Glenn Morris, Nigel Paneth, Ira H. Gewolb

Research output: Contribution to journalArticle

170 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)407-412
Number of pages6
JournalNature
Volume548
Issue number7668
DOIs
StatePublished - Aug 24 2017

ASJC Scopus subject areas

  • General

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