Standards for fecal microbiota transplant: Tools and therapeutic advances

Ilia Belotserkovsky; Lisa M Stabryla; Monique Hunter; Jessica Allegretti; Benjamin J Callahan; Paul E Carlson; Phillip J Daschner; Maryam Goudarzi; Cyril Guyard; Scott A Jackson; Krishna Rao; Stephanie L Servetas; Harry Sokol; Jennifer A Wargo; Shawn Novick

doi:10.1016/j.biologicals.2024.101758

Standards for fecal microbiota transplant: Tools and therapeutic advances

Biologicals. 2024 Mar 21:86:101758. doi: 10.1016/j.biologicals.2024.101758. Online ahead of print.

Authors

Affiliations

¹ BIOSTER Technological Research Institute, Lyon, France.
² Complex Microbial Systems Group, Biosystems and Biomaterials Division, National Institute of Standards and Technology, Gaithersburg, MD, USA.
³ Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
⁴ Bioinformatics Research Center, North Carolina State University, Raleigh, 27606, USA; Department of Population Health and Pathobiology, North Carolina State University, Raleigh, 27607, USA.
⁵ Laboratory of Mucosal Pathogens and Cellular Immunology, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
⁶ Division of Cancer Biology, National Cancer Institute, Bethesda, MD, USA.
⁷ SCIEX, Framingham, USA.
⁸ Department of Internal Medicine, Division of Infectious Diseases, University of Michigan Medical School, Ann Arbor, MI, USA.
⁹ Assistance Publique des Hôpitaux de Paris, Saint-Antoine Hospital, Gastroenterology Department, Paris, France.
¹⁰ Departments of Surgical Oncology and Genomic Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
¹¹ BioPhia Consulting, Inc., 7307 W. Green Lake Dr. N., Seattle, WA, 98103, USA. Electronic address: Snovick.cmc@gmail.com.

PMID: 38518435
DOI: 10.1016/j.biologicals.2024.101758

Abstract

Fecal microbiota transplantation (FMT) has been demonstrated to be efficacious in preventing recurrent Clostridioides difficile (C. difficile) infections, and is being investigated for treatment of several other diseases including inflammatory bowel disease, cancer, obesity, liver disease, and diabetes. To speed up the translation of FMT into clinical practice as a safe and standardized therapeutic intervention, additional evidence-based technical and regulatory guidance is needed. To this end in May of 2022, the International Alliance for Biological Standardization (IABS) and the BIOASTER Microbiology Technology Institute hosted a second webinar to discuss key issues still impeding the advancement and standardization of FMT. The goal of this two-day webinar was to provide a forum for scientific experts to share and discuss data and key challenges with one another. Discussion included a focus on the evaluation of safety, efficacy, clinical trial design, reproducibility and accuracy in obtained microbiome measurements and data reporting, and the potential for standardization across these areas. It also focused on increasing the application potential and visibility of FMT beyond treating C. difficile infections.

Keywords: Efficacy; FMT; Fecal microbiota standards; Live biotherapeutic product (LBP); Measurement bias; Safety; Stability; Standards.