ECOSPOR IV is an open-label extension of Study SERES-012. This study is designed to evaluate the safety, tolerability, and efficacy of a SER-109 treatment regimen in adult subjects 18 years of age or older with recurrent Clostridium difficile infection (RCDI), who received a SER-109 or placebo treatment regimen in Study SERES-012.
- Previously enrolled in SERES-012 and experienced CDI recurrence within 8 weeks after receipt of a treatment regimen
- Positive c. difficile stool toxin assay with 3 or more unformed stools per day for 2 consecutive days
- 3 or more episodes of CDI within the past 12 months
- Females who are pregnant or breastfeeding
- Suspected toxic megacolon
- History of inflammatory bowel disease causing diarrhea
5 stool collections, vital signs, study drug, keeping patient diaries