Fecal microbiota transplantation: a tale of two regulatory pathways
Open Access
- 29 April 2025
- journal article
- review article
- Published by Taylor & Francis in Gut Microbes
- Vol. 17 (1) , 2493901
Abstract
Fecal microbiota transplantation (FMT) is a procedure involving the transfer of intestinal microbiota from a healthy donor to a patient to restore a functional intestinal microbiome. First described in modern science in 1958, the use of FMT has been practiced for decades, but only during the past dozen years have clinical frameworks and legal regulations from competent authorities been developed. Future development of microbiota-derived medical therapies will be shaped by the regulatory frameworks of various jurisdictions. This review examines the historical development and status of FMT regulations in the United States and Europe, with particular attention to their respective approaches to ensuring the safety and quality of the therapeutic product and patient access.Keywords
This publication has 48 references indexed in Scilit:
- Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase III, Randomized, Double-Blind, Placebo-Controlled Trial with a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile InfectionDrugs, 2022
- European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adultsClinical Microbiology and Infection, 2021
- Patients Eligible for Trials of Microbe-Based Therapeutics Do Not Represent the Population With Recurrent Clostridioides difficile InfectionClinical Gastroenterology and Hepatology, 2020
- Fecal microbiota transplant for C. difficile infection: Just say yesAnaerobe, 2019
- Fecal microbiota transplantation (FMT) for C. difficile infection, just say ‘No’Anaerobe, 2019
- Treatment of Severe and Fulminnant Clostridioides difficile InfectionCurrent Treatment Options in Gastroenterology, 2019
- Therapeutic potential of an anaerobic cultured human intestinal microbiota, ACHIM, for treatment of IBSBest Practice & Research Clinical Gastroenterology, 2019
- Rectal bacteriotherapy for recurrent Clostridium difficile-associated diarrhoea: results from a case series of 55 patients in Denmark 2000–2012Clinical Microbiology and Infection, 2015
- Fecal microbiome transplantation for recurrent Clostridium difficile infection: Report on a case seriesAnaerobe, 2013
- Treating Clostridium difficile Infection With Fecal Microbiota TransplantationClinical Gastroenterology and Hepatology, 2011