Probiotics treatment shows promise for smallest preemies

PAbbie Roth

rematurity is one of the greatest health risks to newborns in Ohio. In 2017, the March of Dimes reported that 10.4 percent of births in Ohio were preterm. And one of the biggest risks to premature babies is necrotizing enterocolitis, or NEC.

NEC is an aggressive disease characterized by inflammation and death of the intestine. Despite decades of research, 10 percent of infants born weighing less than 3.5 pounds will develop NEC. They receive antibiotics and, many times, need to have a portion of their bowel removed. But even with treatment, up to 30 percent of these infants will die from NEC.

Researchers are investigating several avenues to improve the prospects for infants with the disease, from stem cells to medications and probiotics.

A healthy microbiome — the ecosystem of microorganisms that live in and on our bodies — is essential to good health. The field of microbiome research is rapidly growing and teaching us that the multitudes of organisms that live symbiotically within us are responsible for more of our health than we imagined.

So, preventing NEC by fortifying the microbiome with probiotics seems like a good idea. And it’s one that has been tried a few times with varying degrees of success.

In previous instances, free-living probiotics — those “good” microorganisms that adults get from things such as yogurt or supplements — are given to premature infants with breast milk or formula. Though lab studies show preventive benefits, clinical results have been inconclusive. Additionally, administering high and frequent doses of probiotics carries a risk of septicemia from the live bacteria.

In recent years, a group of experts in NEC, microbiomes and biofilms at Nationwide Children’s Hospital has been collaborating to develop a novel delivery system of the probiotic Lactobacillus reuteri, which has been shown in lab studies to reduce the incidence of NEC.

Biofilms are the fortresses that communities of bacteria build to protect themselves from external threats. With this protection, pathogenic bacteria can become resistant to antibiotics, making it difficult to treat infections. But what if biofilms could be used for good?

That is exactly what the team of doctors — Gail Besner, Steven Goodman, Michael Bailey and Lauren Bakaletz — had in mind for treating NEC. They introduced cultures of L. reuteri to porous, biocompatible, biodegradable microspheres, which resulted in the bacteria sticking to the microspheres and forming a biofilm. These biofilms protected the probiotics as they traveled through the highly acidic stomach and increased their adherence to the gastrointestinal tract compared with free-living bacteria.

In lab studies, the use of probiotic biofilms resulted in a pronounced reduction in NEC, after only a single dose. In further lab experiments, the researchers found that adding the sugar maltose to the mix increased the effectiveness of the single-dose probiotic.

So what now? How do we use these innovations to help the babies?

The technology has been licensed to Scioto Biosciences, where the team is working with the U.S. Food and Drug Administration to determine the next steps required to get it into the clinic.

It helps that all of the components — the probiotic, the microsphere and the maltose — are “generally recognized as safe” by the FDA. But a clinical trial to prove safety and efficacy will ultimately be needed before neonatologists can add probiotic biofilms to their NEC-fighting arsenal.