SER-109 (Vowst™) in Prevention of Clostridiodes Difficile in High-Risk Population

• Angelina Aubain, Biochemistry, Spelman College

• Dr. Alfred Bacon, Infectious Disease, Christiana Care Hospital

The gastrointestinal tract is comprised of a heterogeneous population of bacteria that shapes the microbial community in sustaining homeostasis, facilitating food fermentation, providing a barrier against pathogenic organisms, facilitating vitamin biosynthesis, and regulating both metabolism and immune response. Decline of bacterial variance within the microbiome compromises the interaction between the host and the immune system, creating optimal conditions for C. Difficile, a spore-forming and toxin-producing bacterium (TcdA and TcdB) predominantly found within the intestines.  SER-109, a microbial therapeutic agent, is derived from fecal microbiota and consists of Firmicute spores, preventing the recurrence of Clostridiodes difficile in high-risk patients. Mixed results have occurred with probiotics as a way of preventing C.difficile disease. This protocol proposes the initiation of SER-109 as an intervention in patients at high risk for C difficile disease following a course of antibiotic treatment. The goal is to determine whether this biotherapeutic agent is capable of preventing or ameliorating the range of disease manifested by C. difficile  To test the proposal a randomized, placebo-controlled trial will be conducted at Christiana Care Hospital’s Newark Campus, where 50 ICU patients at high risk for C. difficile infection will be enrolled to evaluate the efficacy of SER-109 as a preventative treatment. No probiotics will be permitted during the 6-week trial period, and daily stool numbers and clinical status will be monitored. Chi-square analysis will be used to evaluate outcomes, with an anticipated infection rate of 15%, based on literature reporting an overall hospital-acquired C. difficile rate of 14.9%. If successfully funded and completed, the study has the potential to advance microbiome-based therapeutics and reduce C. difficile infection in high-risk patient populations.