The first death from a fecal transplant occurred during a clinical trial run by Boston-based Massachusetts General Hospital, according to new details published Oct. 30 in the New England Journal of Medicine.
The 73-year-old man who died in spring 2019 had a rare blood condition and was a participant in a clinical trial at the teaching hospital. His death has been attributed to a rare type of bacteria that causes E. coli, found in fecal transplant materials he received. The fecal transplant capsules he was given were produced by the hospital in November 2018, with all fecal materials sourced from one stool donor.
Massachusetts General Hospital scientists started screening for E.coli and other similar bacteria in January 2019, but did nottest capsules they had already produced.
"We didn't think of it. The prevalence of these organisms in healthy individuals is so low," Elizabeth Hohmann, MD, an author of the paper and infectious disease specialist at the hospital's lab that made the capsules, told STAT. She added that, in retrospect, it was obvious all capsules should have been tested.
Capsules made of material from the same donor were given to 21 other individuals, according to the paper cited by STAT. One other person experienced serious side effects but recovered. Multiple subjects tested positive for the bacteria but were not sickened.
The stool donor, dubbed donor No. 46, is healthy and didn't require treatment. Because of this, donor No. 46 was not informed about the incidents associated with her stool, a hospital spokesperson told STAT.
The U.S. Food and Drug Administration will hold a meeting about the safety and regulation of fecal transplants Nov. 4.
The first death from a fecal transplant occurred during a clinical trial run by Boston-based Massachusetts General Hospital, according to new details published Oct. 30 in the New England Journal of Medicine.