NEW YORK (Reuters Health) – A combination of three probiotics did not reduce late-onset sepsis or mortality in very preterm infants, a new trial shows.
Dr. Susan E. Jacobs of The Royal Women’s Hospital in Melbourne, Australia, and her colleagues found that a mixture of Bifidobacterium infantis, Streptococcus thermophilus, and Bifidobacterium lactis was no better than a maltodextrin placebo for preventing the complication in babies born before 21 weeks gestation and weighing less than 1,500 grams.
However, a post-hoc analysis found infants were less likely to develop necrotizing enterocolitis (NEC) of Bell stage 2 or greater if they received probiotics.
Some studies have suggested that probiotics can reduce NEC and mortality, while these studies did not find an effect on late-onset sepsis, Dr. Jacobs and her team write. However, they add, these studies were not adequately powered. To provide a more definitive answer, the researchers randomly assigned 1,099 infants born in Australia or New Zealand between October 2007 and November 2011 to receive the probiotic combination or placebo.
The primary outcome, at least one episode of late-onset sepsis, occurred in 16.2% of infants in the control group, and 13.1% of babies who received probiotics (p=0.16), while about 5% of babies in both groups died. NEC Bell stage 2 or more occurred in 2.0% of the probiotic group and 4.4% of the control group (p=0.03).
“Although this probiotic combination did not affect all-cause mortality, it appears to be safe, cheap, and readily implemented,” Dr. Jacobs and her colleagues state.
The current findings, although they are negative, are important, said Dr. Josef Neu, a neonatologist and professor at the University of Florida College of Medicine in Gainesville who has studied NEC in preterm infants but did not take part in Dr. Jacobs’ research. Given that the effects of probiotics are strain-specific, other probiotics could be helpful, he added.
But the findings should not be interpreted to mean that physicians should start routinely treating very preterm infants with probiotics to prevent NEC, according to Dr. Neu.
“One of the problems is that this is not a very well regulated area,” he told Reuters Health. “Probiotics are actually a food and not a pharmacological agent. And the probiotics are live bacteria that you are administering to these preterm babies, and many of these babies are immunocompromised.”
Prospective studies are in the planning stages or now underway that will be adequately powered to determine whether certain strains of probiotics can prevent NEC in very preterm infants, he added, although it will be a few years before results are available.
“We need to be careful moving forward,” he said. “Let’s not be so exuberant about using probiotics in all premature babies in the U.S. and Canada and the world to potentially prevent something that we don’t even know it’s going to prevent.”