A healthy gut microbiome helps maintain stasis, and defend against pathogenic infections. The gut microbiome provides important protective, immune regulatory and metabolic functions, and as such provides a central line of resistance against the growth of opportunistic pathogens, including C. diff.

In its balanced state, this community of microbiota plays a critical role in the conservation of mucosal immune function, epithelial barrier integrity, motility, and nutrient absorption.

But even a slight disturbance in normal gut microbiota can lead to dysbiosis, creating an environment receptive to a host of diseases as well as C. diff infection.

A major and urgent threat, according to the US Centers for Disease Control and Prevention, C. diff infection is one of the most common healthcare-associated infections in US hospitals, affecting approximately half a million people annually.

Approximately half a million cases of CDI occur annually in the United States, establishing a serious health challenge, with a rate of recurrence that leads to mortality of close to 30,000. These infections are spread across both community-associated CDI and healthcare-associated CDI.

Antibiotics are standard treatment of initial CDI. However, they fail to address the underlying dysbiosis associated with recurrence. and their effect on the delicate gut microbiota can also further increase the likelihood of recurrence.

Restoration of the gut microbiome homeostasis is essential to rectifying dysbiosis and promoting overall health. One historic approach has been fecal microbiota transplant. However, there are several limitations found across clinical studies, diagnosis, and treatment.