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2015 ; 1
(ä): 39-41
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Treating Clostridium difficile infections: Should fecal microbiota
transplantation be reclassified from investigational drug to human tissue?
#MMPMID29736438
Stuntz M
; des Vignes F
Contemp Clin Trials Commun
2015[Oct]; 1
(ä): 39-41
PMID29736438
show ga
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 in developed countries and the cause of
nearly 30,000 annual deaths in the US. FMT is proving to be more effective at
treating CDI than traditional antibacterial therapy, and reduces the exposure of
valuable antibiotics to potential resistance. A systematic review to assess the
efficacy of FMT for CDI treatment showed that across all studies for recurrent
CDI, symptom resolution was observed in 85% of patients. The United States Food
and Drug Administration currently classifies FMT as an investigational drug,
which imparts overly restrictive regulations that are impossible to apply to FMT
in the same manner as conventional drugs. Reclassification of FMT to a human
cell, tissue, and cellular and tissue-based product could potentially expand
access to this important treatment while maintaining rigorous safety standards.