INSTITUTE CONFIDENTIALITY INSTITUTE REPRESENTATIVES PUBLICATIONS
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December 2015
Treating Clostridium difficile infections: Should fecal microbiota transplantation be reclassified from investigational drug to human tissue?

Mark Stuntz, Franka des Vignes
Contemporary Clinical Trials Communications
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a b s t r a c t

Fecal microbiota transplantation (FMT)has emerged as a highly effective treatment for Clostridium difficile infection(CDI), the most frequent cause of hospital-acquired infectious diarrhea indeveloped countries and the cause of nearly 30,000 annual deaths in the US. FMTis proving to be more effective at treating CDI than traditional antibacterialtherapy, and reduces the exposure of valuable antibiotics to potentialresistance. A systematic review to assess the efficacy of FMT for CDI treatmentshowed that across all studies for recurrent CDI, symptom resolution wasobserved in 85% of patients. The United States Food and Drug Administrationcurrently classifies FMT as an investigational drug, which imparts overlyrestrictive regulations that are impossible to apply to FMT in the same manneras conventional drugs. Reclassification of FMT to a human cell, tissue, andcellular and tissue-based product could potentially expand access to thisimportant treatment while maintaining rigorous safety standards.

Keywords
Clostridium; Difficile; FMT