title: Laboratory Testing of Donors and Stool Samples for Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection.
abstract: Fecal microbiota transplantation is an efficacious and inexpensive therapy for recurrentClostridium difficileinfection, 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.
authors.affiliation: Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA.
authors.forename: Michael H
authors.identifier: 0000-0002-6181-4599
authors.initials: MH
authors.lastname: Woodworth
authors.affiliation: Emory University, Atlanta, Georgia, USA.
authors.forename: Emma M
authors.initials: EM
authors.lastname: Neish
authors.affiliation: Department of Pathology, Boston University, Boston, Massachusetts, USA.
authors.forename: Nancy S
authors.initials: NS
authors.lastname: Miller
authors.affiliation: Division of Digestive Diseases, Emory University, Atlanta, Georgia, USA.
authors.forename: Tanvi
authors.initials: T
authors.lastname: Dhere
authors.affiliation: Department of Pathology, Emory University, Atlanta, Georgia, USA.
authors.forename: Eileen M
authors.initials: EM
authors.lastname: Burd
authors.affiliation: Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Carpentieri
authors.affiliation: Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA.
authors.forename: Kaitlin L
authors.initials: KL
authors.lastname: Sitchenko
authors.affiliation: Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA colleen.kraft@emory.edu.|Department of Pathology, Emory University, Atlanta, Georgia, USA.
authors.forename: Colleen S
authors.initials: CS
authors.lastname: Kraft
mesh_terms: D016360:Clostridioides difficile / Q000302:isolation & purification; D003015:Clostridium Infections / Q000382:microbiology / Q000628:therapy*; D000069467:Fecal Microbiota Transplantation / Q000009:adverse effects / Q000379:methods* / Q000592:standards*; D005243:Feces / Q000382:microbiology*; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D055502:Secondary Prevention / Q000379:methods*; D014019:Tissue Donors; D014481:United States; D014486:United States Food and Drug Administration
keywords: Clostridium difficile; FMT; fecal microbiota transplantation; gut microbial therapeutics; microbiome; stool donor screening