Evolution of FMT – From early clinical to standardized treatments. (April 2022)

• Record Type: Journal Article
• Authors: Servetas, Stephanie L.; Daschner, Phillip J.; Guyard, Cyril; Thomas, Vincent; Affagard, Herve; Sergaki, Chrysi; Sokol, Harry; Wargo, Jennifer A.; Wu, Gary D.; Sabot, Philippe
• Is Part Of: Biologicals. Volume 76(2022)
• Page Start: 31
• Page End: 35
• Publication Date: 2022-04
• Subjects: Fecal microbiota standards -- FMT -- Standards; Biological products -- Standards -- Periodicals; Biological Products -- Periodicals; Biological Products -- standards -- Periodicals; Produits biologiques -- Normes -- Périodiques; Biological products -- Standards; Periodicals; 615.37
• DOI: 10.1016/j.biologicals.2022.01.004
• Languages: English
• ISSNs: 1045-1056

Abstract

Abstract: Faecal microbiota transplantation (FMT) is widely reported to be an effective treatment against recurrent Clostridioides difficile infections. Recent clinical studies support the therapeutic use of FMT for several other pathologies including inflammatory bowel disease, several types of cancer, and other functional or metabolic disorders. Initial guidelines are now available to overcome some of the technical and logistical issues for establishing a non-standardized treatment into clinical practice with proper safety and governance. To aid the improvement of guidance and standardization requirements for FMT, the International Alliance for Biological Standardization (IABS) and the BIOASTER Microbiology Technology Institute hosted a joint online workshop in May of 2021. The goal of the webinar was to provide a multi-disciplinary perspective of the ongoing efforts to develop FMT guidelines including technical, regulatory, and standardization requirements. Recognized experts gave insights into state-of-the art approaches and standards developed by international organizations and institutions. Highlights: Faecal microbiota transplantation shows great promise as a therapeutic intervention for numerous diseases. Improved technologies are needed in order to fully characterize donor material for safety and efficacy. A coordinated effort to develop standards to support reproducibility and comparability of microbiome workflows is needed. Recipient screening and evaluation in addition to donor screening could help elucidate mechanisms behind treatment failure.