Laboratory Testing of Donors and Stool Samples for Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection

Fecal microbiota transplantation is an efficacious and inexpensive therapy for recurrent infection, yet its safety is thought to depend on appropriate fecal donor screening. FDA guidance for regulation of this procedure is in flux, but screening and manufacture of fecal material from asymptomatic do...

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Bibliographic Details
Published in:	Journal of clinical microbiology 2017-04, Vol.55 (4), p.1002-1010
Main Authors:	Woodworth, Michael H, Neish, Emma M, Miller, Nancy S, Dhere, Tanvi, Burd, Eileen M, Carpentieri, Cynthia, Sitchenko, Kaitlin L, Kraft, Colleen S
Format:	Article
Language:	eng
Subjects:	Clostridium difficile Clostridium difficile - isolation & purification Clostridium Infections - microbiology Clostridium Infections - therapy Fecal Microbiota Transplantation - adverse effects Fecal Microbiota Transplantation - methods Fecal Microbiota Transplantation - standards Feces - microbiology Humans Mass Screening - methods Minireview Secondary Prevention - methods Tissue Donors United States United States Food and Drug Administration
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Summary:	Fecal microbiota transplantation is an efficacious and inexpensive therapy for recurrent infection, yet its safety is thought to depend on appropriate fecal donor screening. FDA guidance for regulation of this procedure is in flux, but screening and manufacture of fecal material from asymptomatic donors present many challenges to clinical laboratories. This minireview summarizes FDA regulatory changes, principles of donor selection, and recommended laboratory screening practices for fecal microbiota transplantation.
ISSN:	0095-1137 1098-660X