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

Author

Listed:
  • Pinaki Panigrahi

    (Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center
    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)

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.

Suggested Citation

  • Pinaki Panigrahi & Sailajanandan Parida & Nimai C. Nanda & Radhanath Satpathy & Lingaraj Pradhan & Dinesh S. Chandel & Lorena Baccaglini & Arjit Mohapatra & Subhranshu S. Mohapatra & Pravas R. Misra &, 2017. "A randomized synbiotic trial to prevent sepsis among infants in rural India," Nature, Nature, vol. 548(7668), pages 407-412, August.
  • Handle: RePEc:nat:nature:v:548:y:2017:i:7668:d:10.1038_nature23480
    DOI: 10.1038/nature23480
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    Cited by:

    1. Johannes Haushofer & Michael Kremer & Ricardo Maertens & Brandon Joel Tan, 2021. "Water Treatment and Child Mortality: Evidence from Kenya," NBER Working Papers 29447, National Bureau of Economic Research, Inc.
    2. Aamer Imdad & Faseeha Rehman & Evans Davis & Deepika Ranjit & Gamael S. S. Surin & Suzanna L. Attia & Sarah Lawler & Abigail A. Smith & Zulfiqar A. Bhutta, 2021. "Effects of neonatal nutrition interventions on neonatal mortality and child health and development outcomes: A systematic review," Campbell Systematic Reviews, John Wiley & Sons, vol. 17(1), March.
    3. Jie Gao & Lei Wang & Jing Jiang & Qian Xu & Nianyi Zeng & Bingyun Lu & Peibo Yuan & Kai Sun & Hongwei Zhou & Xiaolong He, 2023. "A probiotic bi-functional peptidoglycan hydrolase sheds NOD2 ligands to regulate gut homeostasis in female mice," Nature Communications, Nature, vol. 14(1), pages 1-15, December.

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