A research team at the University of Nebraska Medical Center College of Public Health has determined that a special mixture of good bacteria in the body reduced the incidence of sepsis in infants in India by 40 percent at a cost of only $1 per infant.

The findings were reported in the Aug. 16 issue of the journal Nature.

Pinaki Panigrahi, MD, PhD, professor, epidemiology and pediatrics, Center for Global Health and Development, and his colleagues in the College of Public Health, led the international research team. The results reflect a culmination of 15 years of research and could seriously impact infant health worldwide.

The special mixture included a probiotic called Lactobacillus plantarum ATCC–202195 combined with fructo–oligosaccharide (FOS), an oral synbiotic preparation developed by Dr. Panigrahi.

"This is the largest clinical trial of probiotics in newborns funded by the National Institutes of Health," Dr. Panigrahi said. The team enrolled more than 4,500 newborns from 149 villages in the Indian province of Odisha and followed them for their first 60 days, the most critical period when they get sick and die.

During their first days of life, the newborns were administered the oral preparation for seven days.

Results of the randomized, double–blind, placebo–controlled study showed that sepsis and deaths in the first two months of infancy were reduced by 40 percent, more than twice the anticipated reduction of 20 percent. The synbiotic treatment also lowered respiratory tract infections.

The effectiveness demonstrated in Dr. Panigrahi’s study was so successful the study was halted early.

The probiotic formula could be a "very cheap oral sepsis vaccine," Dr. Panigrahi said.

Few trials on the use of probiotics to prevent sepsis have focused on newborns, whose largely naive immune system and less complex intestinal environment would allow the probiotic to grow.

"We were concerned when the data safety and monitoring board stopped the study prematurely. 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. 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," Dr. Panigrahi said.

"This study has to be replicated in different countries and under different circumstances. We maintained tight controls on the administration of the synbiotic and conducted a rigorous follow–up which will not be available in real life," he said.

"We have to find out why respiratory infections went down. How does this treatment affect the lungs?"

The intestinal system is the largest immune organ in the body, Dr. Panigrahi said. "If you took it apart and spread out the villi – small, finger–like projections that extend into the small intestine – it would cover a tennis court. And, it’s loaded with lymphoid cells. So, if you want to stimulate the body’s immunity, go to the intestine."