Standardized fecal microbiota preparation, rectally administered
Prevention of recurrence of C. difficile infection in adults following antibiotic treatment for rCDI
FDA-approved December 2022. PUNCH CD3 trial: 70.6% sustained clinical response at 8 weeks vs 57.5% placebo. First FDA-approved fecal microbiota product.
Rectal administration only. Requires healthcare facility. Contains live organisms from human donors with extensive screening. Not for primary CDI.