A randomized synbiotic trial to prevent sepsis among infants in rural India
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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Preliminary clinical trials of probiotic interventions for at-risk children have yielded promising results for reducing risk for GI problems, sepsis, autism spectrum disorder, and attention deficit hyperactivity disorder.
“Beyond correlation, preliminary clinical trials of probiotic interventions for at-risk children have yielded promising results with regards to reducing risk for GI problems (Indrio et al., 2014;Weizman et al., 2005), sepsis (Panigrahi et al., 2017), and even autism spectrum disorder (ASD) (Parracho et al., 2010;Partty et al., 2015) and attention deficit hyperactivity disorder (Partty et al., 2015)”
From The Microbiota-Gut-Brain Axis (2019) · cites this paper as Panigrahi et al., 2017
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- Authors
- Panigrahi, P., Parida, S., Nanda, N. C., Satpathy, R., Pradhan, L., Chandel, D. S., Baccaglini, L., Mohapatra, A., Mohapatra, S. S., Misra, P. R., Chaudhry, R., Chen, H. H., Johnson, J. A., Morris, J. G., Paneth, N., & Gewolb, I. H.
- Affiliations
- University of Nebraska Medical Center (US)
- Sriram Chandra Bhanja Medical College Hospital (IN)
- Ispat General Hospital (IN)
- Asian Institute of Public Health (IN)
- All India Institute of Medical Sciences (IN)
- University of Maryland, Baltimore (US)
- University of Florida (US)
- Michigan State University (US)
- Corresponding author
- Panigrahi, Pinaki
- ORCID
- Venue
- Nature
- Published
- 2017-08-16
- Volume
- 548
- Issue
- 7668
- Pages
- 407-412
- ISSN
- 0028-0836 (ISSN-L)
- 1476-4687
- OpenAlex
- W2749328728
- Cited by
- 526
- References
- 2
- Citations by year
- 2026: 29 · 2025: 42 · 2024: 51 · 2023: 45 · 2022: 50 · 2021: 87 · 2020: 70 · 2019: 71 · 2018: 59 · 2017: 22
- FWCI
- 56.91
- Type
- journal article
- Language
- en
- Update notices
- erratum (2017-11-29)
- Open access
- closed
- Locations
- Nature (publishedVersion)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- Funders
- Indian Council of Medical Research
- Ministry of Health and Family Welfare
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (U01HD040574, R01HD053719)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Neonatal and Maternal Infections
- Health Sciences › Nursing › Nutrition and Dietetics › Infant Nutrition and Health
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Keywords
- neonatal sepsis, synbiotics, Lactobacillus plantarum, fructooligosaccharides, sepsis prevention, lower respiratory tract infection, neonates, probiotics, prebiotics, rural India, infant mortality
- MeSH terms
- Adult, Double-Blind Method, Female, Follow-Up Studies, Humans, India, Infant, Infant, Newborn, Oligosaccharides, Sepsis, Lactiplantibacillus plantarum, Young Adult, Synbiotics
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