Fecal microbiota transplantation: A practical update for the infectious disease specialist

Thomas Moore, Andres Rodriguez, Johan S. Bakken

Research output: Contribution to journalArticlepeer-review

56 Scopus citations

Abstract

Fecal microbiota transplantation (FMT) has been shown to be a superior therapeutic modality for the treatment of recurrent Clostridium difficile infection (RCDI). Recently the US Food and Drug Administration (FDA) determined that human stool should be classified as a biological agent and its use should be regulated to ensure patient safety. Consequently, the FDA determined that prescribers of FMT must possess an approved investigational new drug (IND) permit to administer FMT for the purpose of conducting research or treating any gastrointestinal condition other than RCDI. Although an IND is not required for use of FMT to treat RCDI, an IND is strongly encouraged and may ultimately be required. This article provides step-by-step guidance to infectious disease specialists on how to navigate the regulatory requirements and successfully obtain an IND before they can begin to use FMT as part of their clinical practice.

Original languageEnglish (US)
Pages (from-to)541-545
Number of pages5
JournalClinical Infectious Diseases
Volume58
Issue number4
DOIs
StatePublished - Feb 15 2014

Keywords

  • Clostridium difficile
  • diarrhea
  • fecal microbiota transplantation
  • recurrent

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