Synbiotic Treatment Significantly Reduces Infant Sepsis Deaths in India

In India, where young infant fatalities due to sepsis are all too common, researchers recently conducted a study indicating that the risk of sepsis can be decreased with a combination of probiotics and prebiotics.

In 2009, the World Health Organization (WHO) reported that of the nearly 4 million neonatal deaths that occur around the world each year, about 1 million occur due to neonatal sepsis or pneumonia. Neonatal sepsis is an infection in the blood that spreads throughout the body affecting an infant in the first 3 months of life. Symptoms can often appear within the first 24 hours of life in infants who have been exposed to bacterial, viral, or fungal pathogens such as group B streptococcus or the herpes simplex virus from their mothers during birth. An infant with sepsis will show signs such as lethargy, breathing difficulty, poor feeding, and change in temperature, and in most cases of early onset sepsis, symptoms will appear within the first 24 to 48 hours of life.

Researchers from the University of Nebraska Medical Center, in conjunction with researchers at various institutions in India, recently conducted a study in which they were able to significantly reduce neonatal sepsis deaths.

In the study, which was recently published in the journal Nature, the researchers tested the effects of a probiotic and prebiotic combination — known as a synbiotic – on infants in India. The randomized, double-blind, placebo-controlled trial included 4,556 infants from 149 randomly chosen villages in India’s state of Odisha, with 2,278 infants each receiving either the synbiotic or a placebo. The infants were at least 2,000 grams (approximately 4.4 pounds) at birth and born at 35 weeks of gestation or more, with the study’s authors noting that low birth weight and preterm birth predispose infants to sepsis. The infants enrolled in the study received an oral preparation of the probiotic Lactobacillus plantarum, live bacteria beneficial to the digestive system, along with the prebiotic fructooligosaccharide (FOS) to help the probiotic grow and colonize the gut.

The study’s lead author, Pinaki Panigrahi, MD, PhD, says that this study is the result of about 20 years of work researching neonatal sepsis, after finding in seminal observations that the cause of such deadly infections was an absence of good bacteria and low bacterial diversity in infants’ guts.

“In other words, it is not the presence of any virulent bug that caused disease, rather, absence of good bacteria that could have prevented disease,” Dr. Panigrahi explained in an interview with Contagion^®. After conducting surveillance in parts of India where infant sepsis deaths occur most, he worked to screen 280 probiotic strains to find one that effectively blocked colonization and invasion by bacterial pathogens in infants’ intestines, eventually identifying L. plantarum as an effective candidate. “We then mixed this with FOS to provide the food these bacteria need in the colon and conducted another hospital-based trial. This time, the synbiotic combination colonized for up to four months in the infant gut, and we launched the large trial to test its effectiveness.”

The researchers followed the infants in the trial for the first 60 days of life and observed a 40% decrease in the combination of sepsis and death during that period. [KR1] In addition, they saw an unexpected reduction in respiratory tract infections which suggests that the synbiotic created an overall immune boosting phenomenon that the researchers say they intend to study in detail.

“We have shown the scientific evidence, and also from an operational standpoint this can be delivered at home with assistance from village level volunteers,” said Dr. Panigrahi to Contagion^®, noting that his team’s findings may have potential impact on other chronic diseases linked to gut bacteria. “We can probably stop overcrowding of the GI tract and repeated GI infections in early childhood, and in turn, a condition called tropical enteropathy or gut dysfunction that gives rise to stunting. This will be even a much bigger contribution to the health and development of any society.”

[KR1]They observed a 40% decrease in death due to sepsis? This is a little unclear.