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Abstract Title:

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

Abstract Source:

Nature. 2017 08 24 ;548(7668):407-412. Epub 2017 Aug 16. PMID: 28813414

Abstract Author(s):

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

Article Affiliation:

Pinaki Panigrahi

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 fewdeaths (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.

Study Type : Human Study

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