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Review
. 2017 Apr;55(4):1002-1010.
doi: 10.1128/JCM.02327-16. Epub 2017 Jan 11.

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

Michael H Woodworth  1 , Emma M Neish  2 , Nancy S Miller  3 , Tanvi Dhere  4 , Eileen M Burd  5 , Cynthia Carpentieri  1 , Kaitlin L Sitchenko  1 , Colleen S Kraft  6   5
Affiliations
Review

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

Michael H Woodworth et al. J Clin Microbiol. 2017 Apr.

Abstract

Fecal microbiota transplantation is an efficacious and inexpensive therapy for recurrent Clostridium difficile 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.

Keywords: Clostridium difficile; FMT; fecal microbiota transplantation; gut microbial therapeutics; microbiome; stool donor screening.

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