The FDA warning relates to the risk of serious or life-threatening infections occurring due to the use of fecal microbiota for transplantation, linked to bacterial infections caused by multi-drug resistant organisms.
With the recent cases that sparked the FDA warning, two immunocompromised adults received investigational fecal microbiota. The two patients developed invasive infections that were triggered by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli. The therapeutic agent administered to the two people was prepared from stool obtained from the same donor.
With fecal transplants (or ‘fecal bacteriotherapy‘) the aim to restore the balance between good bacteria and bad bacteria in the colon. Much of the research has been orientated to the treatment of infections causes by Clostridium difficile, which can infect the bowel and cause diarrhoea.
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An investigation, for which the outcome was revealed in June 2019, found that the donor stool and resulting fecal microbiota for transplantation had not been pre-tested for ESBL-producing Gram-negative bacteria prior to use. Subsequent examination, following notification of the adverse events, of the stool donor found the donation material to be positive for ESBL-producing E. coli. Metagenomic analysis further showed the contaminant to be identical to the organisms isolated from the two patients.
In the U.S., fecal transplantation does not fall under the same level of strict guidances as with other pharmaceutical preparations. In 2013, the FDA permitted the use of discretion on the part of the treating medical doctor. Following the incident, the FDA is calling for increased protection of the patient.
The protections include the use of donor screening questionnaires, designed to address the types of risk factors that might indicate colonization with multi-drug resistant organisms with the aim of excluding individuals at higher risk of colonization with such antimicrobial resistant microorganisms. This should be followed by microbial testing of donor stool for multi-drug resistant organisms and the subsequent exclusion of any stool that tests positive for such organisms.
