Product Description: Oral immunotherapy BCP formulation containing polyclonal antibodies against the C. difficile spore and its toxins which can aid in the prevention and treatment of C. difficile Associated Disease (CDAD), including antibiotic associated diarrhoea.

Indications and Need: CDAD is a primarily nosocomial disease seen among persons being treated with antibiotics that alter the natural intestinal flora and allow for bacterial overgrowth. It can be seen up until 8 weeks after antibiotic discontinuation. It is a primary cause of antibiotic-associated diarrhoea, the most common cause of diarrhoea in hospitalized patients. CDAD may also cause pseudomembraneous colitis and other serious sequelae. The mortality of this disease in elderly hospitalized patients approaches 15%. Fully 7% of attributed mortality in intensive care unit patients as well as excess hospitalization is attributed to C. difficile. The disease is also beginning to be seen in a community acquired form. Furthermore, antibiotic resistance has developed in hospital strains, which can also cause hospital outbreaks, making C. difficile control a recognized urgent public health and hospital infection control issue. Increases in resistance are expected, and preventing the emergence of such a scenario is of major importance as well.