SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence

Exclusion Criteria

• •1. Females who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
• •2. Known or suspected toxic megacolon and/or known small bowel ileus.
• •3. Active irritable bowel syndrome with diarrhea within the previous 12 months.
• •4. Major gastrointestinal surgery (eg, significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy) or any history of total colectomy or bariatric surgery.
• •5. History of inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 12 months.
• •6. Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2
• •7. Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Patients discharged from an intensive care unit before Day 1 may be enrolled.
• •8. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).
• •9. Absolute neutrophil count \< 500 cells/mm3