by A groundbreaking study conducted by Dr. Gail Besner and her research team at Nationwide Children’s Hospital has found that a biofilm probiotic, specifically a Limosilactobacillus reuteri (Lr) formulation, is effective in preventing necrotizing enterocolitis (NEC) in a piglet model. NEC is a severe and often fatal condition that commonly affects premature infants.
NEC is characterized by inflammation of the intestinal tissues, which can lead to the death of involved intestines. Surgery is often required to remove the necrotic tissue. Dr. Besner and her collaborators, Dr. Michael Bailey and Dr. Steven Goodman, have been working on finding a solution to prevent NEC, and their latest study published in Nature Scientific Reports demonstrates the potential of using a biofilm probiotic.
Traditionally, probiotics have been administered in a planktonic (free-living) state. However, the researchers have developed a novel probiotic system that utilizes the durability of biofilms to improve the administration of probiotics to patients. The biofilm formulation of Lr has shown promising results in previous studies conducted on rodent models.
To further validate their findings, the researchers adapted a challenging piglet model of NEC for their study. Preterm piglets have similarities to preterm infants in terms of size and intestinal anatomy, making them an excellent model for studying NEC. The study included various elements of care that would typically be given to a preterm infant, such as medications, fluids, nasogastric tube feedings, and round-the-clock monitoring.
The data obtained from the piglet model demonstrated the superiority of Lr in its biofilm state compared to planktonic Lr in preventing the morbidity and mortality associated with NEC. Additionally, the biofilm probiotic not only protected the intestines but also showed beneficial effects on the brain. This finding holds significant potential for survivors of NEC.
Joe Trebley, the founder and CEO of Scioto Biosciences, the company that has licensed the biofilm probiotic technology, expressed his enthusiasm about the study’s results. He highlighted the importance of the piglet model in understanding the safety and efficacy of the novel formulation, as it will aid in the planning of future human studies in collaboration with the Food and Drug Administration (FDA).
The research team has previously developed a similar probiotic formulation, SB-121, which has been tested in a clinical trial involving adults with autism spectrum disorder (ASD). The study found that participants experienced improvements in their ASD test outcomes, indicating the potential therapeutic benefits of the probiotic formulation in gut-brain interactions.
The successful piglet study, combined with previous rodent studies and the positive results of the SB-121 clinical trial, provides a strong foundation for progressing to a clinical trial involving neonates at risk of developing NEC. Dr. Besner expressed her excitement about continuing this research, with the hope of providing infants born prematurely with additional options to protect them from NEC.
Funding for this research was provided through a $2.3 million Small Business Innovation Research (SBIR) grant from the National Institute of General Medical Sciences at the National Institutes of Health. Dr. Besner, Dr. Bailey, and Dr. Goodman are all scientific founders of Scioto Biosciences, further emphasizing the potential of their groundbreaking probiotic technology.
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1. Source: Coherent Market Insights, Public sources, Desk research
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