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 and Ira H. Gewolb
Additional contact information
Pinaki Panigrahi: Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center
Sailajanandan Parida: SCB Medical College
Nimai C. Nanda: Ispat General Hospital
Radhanath Satpathy: Asian Institute of Public Health
Lingaraj Pradhan: Capital Hospital
Dinesh S. Chandel: Agricultural & Occupational Health, Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center
Lorena Baccaglini: Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center
Arjit Mohapatra: Asian Institute of Public Health
Subhranshu S. Mohapatra: Asian Institute of Public Health
Pravas R. Misra: Asian Institute of Public Health
Rama Chaudhry: All India Institute of Medical Sciences
Hegang H. Chen: University of Maryland School of Medicine
Judith A. Johnson: Emerging Pathogens Institute, University of Florida
J. Glenn Morris: Emerging Pathogens Institute, University of Florida
Nigel Paneth: Pediatrics & Human Development, College of Human Medicine, Michigan State University
Ira H. Gewolb: College of Human Medicine, Michigan State University, East Lansing

Nature, 2017, vol. 548, issue 7668, 407-412

Abstract: 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.

Date: 2017
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DOI: 10.1038/nature23480

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