Fecal Transplant Associated with One Patient Death

The FDA warns of the potential risk of transmitting multidrug-resistant organisms (MDROs) via fecal transplants.

Fecal microbiota for transplantation (FMT) is a treatment used for patients infected with the bacterium Clostridium difficile who have not responded to standard treatment regimens. According to guidance issued by the U.S. Food and Drug Administration (FDA) in 2013, the agency expects physicians to obtain adequate consent for the use of FMT from the patient or his/her legally authorized representative, which includes at a minimum a statement that the use of FMT to treat C. difficile is investigational and a discussion of its potential risks.

Those risks are real and recently manifested themselves for two immunocompromised adults that received FMT treatments prepared from the stool obtained from a single donor. Both patients developed invasive infections caused by extended-spectrum beta-lactamase (ESBL) – producing Escherichia coli, and one died as a result. Neither the donor stool nor the FMT treatment material were tested for ESBL-producing, gram-negative organisms before use but were found to be positive for the same organisms after the infections in the two patients became known.

According to Openbiome, a nonprofit stool bank based in Cambridge, Massachusetts, the infection of the two patients underscores the importance of proper screening and clinical oversight for all fecal transplant procedures. The FDA also announced new protections that it has put in place going forward: donor screening with questions that specifically address risk factors for colonization with MDROs, the exclusion of individuals at higher risk for colonization with MDROs and MDRO testing of donor stools and the exclusion of stools that test positive for MDROs.




David Alvaro, Ph.D.

David is Scientific Editor in Chief of the Pharma’s Almanac content enterprise, responsible for directing and generating industry, scientific and research-based content, including client-owned strategic content, in addition to serving as Scientific Research Director for That's Nice. Before joining That’s Nice, David served as a scientific editor for the multidisciplinary scientific journal Annals of the New York Academy of Sciences. He received a B.A. in Biology from New York University in 1999 and a Ph.D. in Genetics and Development from Columbia University in 2008.