VE303 for prevention of recurrent C difficile infection

Summary

This is a double-blind, placebo-controlled study, comparing the investigational drug VE303 to placebo. The purpose of RESTORATiVE303 is to see if the investigational drug, VE303, is safe and effective in preventing participants from having another episode of Clostridioides difficile infection (CDI).
VE303 is an investigational drug that has 8 strains of live bacteria. These bacteria were selected for inclusion in VE303 because they rarely infect humans (mostly in very weakened patients), they do not carry any toxins that can make you sick, and they are not known to carry any risk of creating or spreading resistance to antibiotics.
Participants will be randomly assigned to 1 of 2 treatment groups (subject will be entered into the treatment group by chance -like flipping a coin). Subjects have two-out-of-three chance of getting VE303 as treatment.
Double-blind means that the Study Doctor, study staff, the study Sponsor, and the participant will not know whether subject is receiving VE303 or placebo. However, in case of an emergency, the Study Doctor or study staff can find out what study drug subjects are taking.

Participation in the study will last approximately 6.5 months. The study begins with a screening period of 10 to 28 days, while participant is taking antibiotics to control the infection. After that, subjects will receive the first dose of study drug. The study includes a total of 7 planned clinic visits and 4 telemedicine visits.