Fecal Microbiota Transplantation for Primary Clostridium difficile Infection

To the Editor: Clostridium difficile infection is a major health problem. 1 Antibiotic treatment is associated with a considerable rate of recurrence of infection and is related to the emergence of antibiotic-resistant bacteria.Recently, fecal microbiota transplantation has been shown to be effective in the treatment of recurrent C. difficile infection. 2 We undertook a proof-of-concept trial (ClinicalTrials.govnumber, NCT02301000) to evaluate the use of fecal microbiota transplantation as treatment for primary C. difficile infection.The trial began on November 25, 2014, and the first patient underwent randomization on February 22, 2015.From February 2015 through November 2017, at six hospitals in Norway, we randomly assigned 21 adult patients with acute C. difficile infection (≥3 loose stools per day and a positive C. difficile stool test) who had not had previous C. difficile infection to recommended treatment in Norway 3 (oral metronidazole at a dose of 400 mg three times a day for 10 days) or fecal microbiota transplantation (one 60-ml enema of anaerobically cultivated human intestinal microbiota) (see the Supplementary Appendix, available with the full text of this letter at NEJM.org). 4,5 Achim Biotherapeutics, which provided the fecal microbiota suspension free of charge to the investigators for the purpose of the trial, had no role in the design, conduct, or analyses of the trial.The protocol, available at NEJM.org, was approved by the institutional review board, and all patients provided written informed consent.The primary end point was clinical cure (firm stool consistency or ≤3 bowel movements per day) with no evidence of recurrence of C. difficile infection when the patient was evaluated at day 70 by an assessor who was unaware of the treatment assignment.Secondary end points were