Feeding newborns a combination of a probiotic bacterium and a prebiotic carbohydrate that promotes healthy bacteria significantly reduced sepsis risk, a large study in rural India found.
“Among secondary outcomes, local infections were diagnosed in 1% of infants, and were reduced by 52% in the synbiotic arm,” the authors write. “The incidence of other infections was low, but had statistically significant risk reductions, ranging from 55% to 80%, in the treatment arm.”
Pinaki Panigrahi, MD, from the Department of Epidemiology, Center for Global Health and Development, College of Public Health at University of Nebraska Medical Center in Omaha, and colleagues published their findings online August 16 in Nature.
Newborns received the oral treatment costing about $1 US per baby beginning on days 2 to 4 of life and then each day for a total of 7 days. The babies were monitored for 60 days.
The group that received the symbiotic combination had a 40% reduction (risk ratio, 0.60; 95% confidence interval, 0.48 – 0.74) in the combined outcome of death and sepsis compared with the placebo group (5.4% vs 9%, respectively.)
That was twice the 20% risk reduction expected, which led the data safety and monitoring board to stop the trial early.
The preparation was well tolerated, and gastrointestinal events “were surprisingly low,” the authors write. Only six cases of abdominal distention (five in the placebo group; one in the treatment group) occurred.
Deaths were rare: four in the placebo group and six in the symbiotic group.
“These findings suggest that a large proportion of neonatal sepsis in developing countries could be effectively prevented using a synbiotic,” the authors write. No effective prevention for sepsis is currently available.
Daniel J. Tancredi, PhD, from the Department of Pediatrics and the Center for Healthcare Policy and Research at University of California, Davis, in Sacramento, points out in an accompanying editorial that taking into account confidence intervals, the relative risk reduction for the symbiotic treatment could be from about 25% to 50%.
In addition, the researchers found substan¬tial reductions in all three components of sepsis they studied — culture-positive sepsis, culture-negative sepsis, and lower respiratory tract infections — as well as in diarrhea and umbilical stump infection in newborns not classified as having sepsis, he explains.
Dr Tancredi praises the large numbers and the rigor of the randomized, placebo-controlled, community-based, double-blind trial.
“The work by Panigrahi and colleagues exem¬plifies how intervention research should be done. Moreover, the trial provides evidence for the effectiveness of a global health interven¬tion that could be used to complement exist¬ing strategies for giving every newborn the best chance to survive and thrive,” he writes.
Researchers found that 27 newborns would need to be treated to prevent one primary outcome. Given that finding, the investment needed to prevent one case of sepsis is about $27, the authors say.
They conducted the trial in 149 randomly chosen villages in Odisha state, which has some of the highest neonatal and infant death rates in the country, the researchers explain.
Sepsis results in about 1 million newborn deaths globally every year, mostly in developing countries. In addition to prematurity, sepsis is a major cause of infant deaths globally (37%).
Using a probiotic in prevention or in combination with other therapies is advantageous as concerns deepen about antibiotic resistance, the authors note.
Study limitations include that researchers did not enroll premature (less than 35 weeks of gestation) or low birthweight (less than 2000 g) babies, groups that have a higher risk of dying from sepsis.
They also excluded 2506 infants (of 7089 births in the study region) who had major causes of morbidity and mortality in the early neonatal period.
Further studies would be needed to determine whether these results would extend to all at-risk infants in developing countries.
The authors have disclosed no relevant financial relationships. Dr Tancredi has received research support and consultation fees from the International Scientific Association for Probiotics and Prebiotics, a nonprofit scientific society.
Nature. Published online August 16, 2017. Article abstract, Editorial extract
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