ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Adult Subjects with Recurrent Clostridioides difficile infection (RCDI)
The purpose of this study is to see how safe and tolerable SER-109 is in keeping Clostridioides difficile infection (CDI) from coming back in people who have recovered from at least a first recurrence of CDI.
Clostridioides difficile, also called “C. diff,” is a type of bacteria that is present in the environment, and in a small percentage of healthy people, can be present in low amounts as part of the bacteria in the intestine or colon. Patients with a history of antibiotic use may develop CDI. Antibiotics can reduce the amount of normal healthy bacteria found in the large intestine or colon, which allows for the growth of C. diff bacteria leading to CDI. C. diff bacteria makes a toxin, or poison, which causes diarrhea that can be very mild and last a few days, or may be severe causing frequent diarrhea, abdominal pain, and may even require life- saving surgery. After recovering from CDI, it is not uncommon for the infection to come back in weeks, months or years later in some people. This is called recurrent CDI and is a significant medical condition for many people.