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Clinical guidelines recommend fecal microbiota transplantation (FMT) following two or more recurrences of Clostridioides difficile infection (CDI). To determine the effectiveness of FMT in patients with at least one recurrence, investigators randomized participants to oral FMT capsule or placebo. Prior to randomization, patients received standard-of-care antibiotics for CDI with improvement of symptoms. The primary endpoint was incidence of recurrent definite CDI (microbiologically confirmed), probable CDI (clinical diagnosis), or death within 56 days of randomization.
Among 153 enrollees (mean age, 66; 86% male, 22% with ≥2 recurrences), 76 were assigned to oral encapsulated FMT and 77 to placebo. At a prespecified analysis, the study was s…