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Updated: Feb 24, 2026
A Controlled Mouse Model for Neonatal Polymicrobial Sepsis
Published on: January 27, 2019
A randomized synbiotic trial to prevent sepsis among infants in rural India
Pinaki Panigrahi1,2, Sailajanandan Parida3, Nimai C Nanda4
1Department of Epidemiology, Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center, Nebraska, USA.
Insights
An oral synbiotic containing Lactobacillus plantarum and fructooligosaccharide significantly reduced sepsis and death in Indian newborns. This intervention offers a promising prevention strategy for neonatal infections in developing countries.
Area of Science:
- Neonatal health
- Microbiome research
- Infectious disease prevention
Background:
- Neonatal sepsis causes a million deaths annually, predominantly in developing nations.
- Current prevention methods for infant sepsis are insufficient.
- Oral synbiotics represent a potential novel intervention.
Purpose of the Study:
- To evaluate the efficacy of an oral synbiotic (Lactobacillus plantarum plus fructooligosaccharide) in preventing sepsis and death in rural Indian newborns.
- To assess the impact of synbiotic supplementation on culture-positive and culture-negative sepsis and lower respiratory tract infections.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted.
- 4,556 eligible newborns were enrolled and monitored for 60 days.
- The intervention group received an oral synbiotic preparation.
Main Results:
- A significant reduction in the combined outcome of sepsis and death was observed in the synbiotic group (risk ratio 0.60).
- The synbiotic intervention also led to significant reductions in culture-positive sepsis, culture-negative sepsis, and lower respiratory tract infections.
- Mortality rates were low in both groups, but favored the synbiotic arm.
Conclusions:
- Oral synbiotic supplementation with Lactobacillus plantarum ATCC-202195 and fructooligosaccharide is effective in preventing neonatal sepsis and death.
- This intervention holds significant potential for reducing the burden of neonatal infections in resource-limited settings.
- Synbiotics offer a feasible and accessible strategy for improving infant survival in developing countries.
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.
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