Endeavor Health researchers find a daily dose of 'good bacteria' improves survival of very low birthweight babies

Evanston, Ill. - Endeavor Health researchers have discovered that a specialized daily probiotic treatment can safely and significantly improve survival rates for very low birthweight babies - often, the most fragile patients in the neonatal intensive care unit.

Babies born with very low birth weights - less than 3.3 pounds - face a high risk of serious stomach and bowel issues, including a dangerous, often fatal disease called necrotizing enterocolitis (NEC). NEC affects 2,000 to 4,000 infants in the United States each year, and with a mortality rate of up to 50%, managing this disease remains one of the most critical challenges in neonatal medicine.

The researchers' findings come from the Connection Study, a massive clinical trial that tested a treatment called IBP-9414 - a probiotic formula of live, helpful bacteria known as L. reuteri to help reduce inflammation and improve resistance against disease-causing pathogens. The study included more than 2,100 very low birth weight babies, some of whom received a daily dose of the bacteria within two days of being born.

The babies who received the probiotic were 27% more likely to survive the condition, and were also significantly less likely to need surgery for NEC. The researchers' findings were published in the journal, Nature Pediatric Research.

"This large-scale trial gives us vital clues on how to better protect our smallest patients," said senior author Dr. Michael Caplan, a neonatal-perinatal clinician, researcher and Chief Scientific Officer at Endeavor Health. "Seeing a clear improvement in survival gives us a lot of hope that we can make this 'good bacteria' a standard part of newborn care."

While the treatment did not completely stop all cases of NEC or change how quickly the babies were able to start digesting regular feedings, it had a large, potentially life-saving benefit overall. Just as importantly, the trial showed the treatment is highly safe for fragile newborns and that the helpful bacteria did not leak into the babies' bloodstreams - a key sign that the treatment is safe to use.

"Safety is always our number one concern when treating tiny, premature infants," Caplan said. "Our findings confirm that this treatment is not only safe, but it can actually save lives and reduce the worst gut problems in these babies."

The research behind this formula of probiotics has been a labor of love for Dr. Caplan. For more than 40 years, he's been working to develop clinical interventions for a range of conditions affecting premature and critically ill infants. That includes leading major clinical trials at Endeavor Health, like the Connections Study.

By proving that this treatment is both safe and effective, Dr. Caplan hopes to help more premature babies survive and grow up healthy. The team plans to continue this work, in collaboration with industry partner Infant Bacterial Therapeutics, by studying how treatments like this can be broadly integrated into neonatal intensive care.