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Comment & Response
February 17, 2015

Fecal Microbiota Transplantation for Clostridium difficile Infection—Reply

Author Affiliations
  • 1Division of Infectious Diseases, Boston Children’s Hospital, Boston, Massachusetts
  • 2Division of Infectious Diseases, Massachusetts General Hospital, Boston

Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2015;313(7):726. doi:10.1001/jama.2014.18619

In Reply: Dr Armstrong and colleagues are concerned that we have compromised a phase 1 study design by incorporating a sample size calculation and by using historical data as a statistical comparator. Traditional phase 1 investigations, or first-in-human studies, are used to determine the dose and schedule of an investigational therapeutic while assessing for potential toxic effects.1