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Special probiotic mixture reduces risk of sepsis in infants, study finds

Dr. Pinaki Panigrahi
UNMC
Dr. Pinaki Panigrahi monitors a baby's progress in a clinical trial in India.

A particular strain of probiotics significantly lowered the incidence of sepsis — a potentially deadly bacterial blood infection — among newborn infants in rural India, according to a recent study published in the journal Nature.

In fact, the effects of the probiotics were so striking, independent experts who were monitoring the research halted the study early, as it would have been unethical to continue to withhold the treatment from half the babies in the study.

This finding, if confirmed by further studies, may lead to a relatively inexpensive treatment that could save many of the 600,000 babies around the world who die of sepsis each year. The infection — which occurs when the body’s immune system stops fighting pathogens and begins to turn on itself, destroying tissue and leading to organ failure — is especially deadly in developing countries, where 40 percent of newborns with severe sepsis do not survive.

“Given the scale of this problem, even modestly effective interventions would save hundreds of thousands of lives and many more millions of dollars, every year,” the study’s authors write.

Not just any strain

Probiotics are live bacteria and yeasts that are believed beneficial for human health, especially the health of the digestive system, although figuring out which probiotic strains are good for which patients has been a challenge for researchers.

In the Nature study, a probiotic strain called Lactobacillus plantarum TCC strain 202195 was combined with a sugar called fructooligosaccharide (FOS).  Found naturally in breastmilk and in such foods as onions, chicory, garlic, asparagus and bananas, FOS helps Lactobacillus plantarum grow and colonize the intestines.

Consumers should not, however, confuse this special mixture with the probiotics found in yogurts, supplements and other consumer products. Despite their hyped health claims, those products have been shown in study after study to be “medically underwhelming.

Study details

The current study — a double-blinded, placebo-controlled trial — is the largest clinical trial of probiotics in newborns ever funded by the National Institutes of Health, according to Dr. Pinaki Panigrahi, its lead author and a pediatrician and epidemiologist at the University of Nebraska’s Center for Global Health and Development.

For the study, Panigrahi and his colleagues enrolled 4,556 newborns from 149 villages in the Indian province of Odisha, which has some of the highest infant mortality rates in all of India.

The babies were randomly assigned to receive an oral symbiotic (in this case, the mixture of Lactobacillus plantarum and FOS) or a placebo for seven days, starting two to four days after birth.

The babies were followed for 60 days. The results were startling. The rate of sepsis and death was 9 percent among the babies taking the placebo, but only 5.4 percent among those taking the oral symbiotic — a reduction of 40 percent.

The treatment also appeared to reduce respiratory infections by 34 percent.

It was because of those numbers that the study was halted early.

“We were concerned when the data safety and monitoring board stopped the study prematurely,” said Panigrahi in a released statement. “We had enrolled just about half of our proposed subjects. Typically, a study is stopped when something is wrong.”

“But, it was a moment of superlative thrill when we learned it was stopped due to early efficacy,” he added. “We were surprised a second time when the complete data analysis showed that respiratory tract infections also were reduced — something we did not anticipate in our population.”

Inexpensive, too

Panigrahi has been searching for a way to stop sepsis in newborns for more than two decades. He told National Public Radio that he and his colleagues screened 280 probiotic strains before deciding that Lactobacillus plantarum, which was isolated from the diaper of a healthy baby in India, was the most promising one.

This particular treatment is also relatively easy and inexpensive to produce and administer, costing only about $1 per baby, the researchers estimate.

And it appears to have no significant side effects.

The next step for Panigrahi and his colleagues is to test the probiotic strain as a preventive treatment for sepsis in infants in other areas of the world.

FMI:  You can read the study in full on Nature’s website.

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