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

Wednesday, 23rd of August 2017

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

Panigrahi P^1,2, Parida S³, Nanda NC⁴, Satpathy R⁵, Pradhan L⁶, Chandel DS⁷, Baccaglini L¹, Mohapatra A⁵, Mohapatra SS⁵, Misra PR⁵, Chaudhry R⁸, Chen HH⁹, Johnson JA¹⁰, Morris JG¹⁰, Paneth N¹¹, Gewolb IH¹².

Author information

1

Department of Epidemiology, Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center, Nebraska, USA.

2

Department of Pediatrics, Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center, Nebraska, USA.

3

Department of Pediatrics, SCB Medical College, Cuttack, Odisha, India.

4

Department of Pediatrics, Ispat General Hospital, Rourkela, Odisha, India.

5

Asian Institute of Public Health, Bhubaneswar, Odisha, India.

6

Department of Pediatrics, Capital Hospital, Bhubaneswar, Odisha, India.

7

Department of Environmental, Agricultural &Occupational Health, Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center, Omaha, Nebraska, USA.

8

Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.

9

Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.

10

Emerging Pathogens Institute, University of Florida, Gainesville, Florida, USA.

11

Departments of Epidemiology, Pediatrics &Human Development, College of Human Medicine, Michigan State University, East Lansing, Michigan, USA.

12

Division of Neonatology, College of Human Medicine, Michigan State University, East Lansing, Michigan, USA.

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.