FDA Announces New Safety Precautions for Fecal Transplants

Federal health officials want additional protections and screening for Fecal Microbiota Transplant (FMT) procedures amid the COVID-19 outbreak, warning that the pandemic could leave patients susceptible to introducing the virus into their system if fecal transplants are not properly screened.

The FDA issued a fecal transplant safety notice on April 9, warning against the use of any FMT product manufactured from stool donated on or after December 1, 2019, until additional screening and testing procedures can be performed to prevent the potential transmission of SARS-CoV-2, which is the virus that causes the respiratory disease COVID-19.

Fecal transplants, which are also referred to as bacteriotherapy, involve the transfer of stool from a healthy donor into the gastrointestinal tract of individuals suffering from recurrent Clostridium difficile infections. This can lead to Clostridium difficile-associated diarrhea (CDAD), with persistent diarrhea, watery stool, abdominal pain and fever.

The agency indicates all donors should be properly screened before healthcare professionals accept donated stool specimens. The recommendations include testing donors’ upper respiratory tract through nasal swabs or other specimens such as rectal swabs or stool donations.

The FDA’s new precautions recommend any donor that has had any instances of suspected or confirmed SARS-CoV-2 infection or exposure be excluded from further donations and any stool donated beginning four weeks prior to the suspected exposure or confirmed infection should be excluded and properly discarded.

The precautions are intended to protect recipients from contracting the disease, as those with existing health conditions can be at an increased risk of serious breathing complications or respiratory failure.

Fecal Transplant Concerns

While FMT is still considered an experimental treatment, it has been found to improve biological factors like food break down, hormones, and the immune response.

Some studies suggest fecal transplant can cure 80% to 90% of C. difficile infections, which are highly resistant to antibiotics. Yet, it is unclear exactly how fecal transplants work to improve health.

Fecal transplants are done using a variety of methods, none of which have been specifically approved or regulated by the FDA. Methods include swallowing pills of stool, freeze dried pieces, and hand mixed fresh stool. Each can be delivered using enemas, colonoscopies, swallowed, or with tubes threaded through the nose to the stomach.

Although unproven, fecal transplants are believed to have higher success rates because they do not disrupt protective bacteria in the gastrointestinal systems like antibiotics, thus allowing for a more effective defense treatment against the infection.

In a safety alert issued on March 12, 2020 the FDA warned that side effects of fecal transplants may include serious adverse events through transmission of pathogenic organisms.

The safety alert warned that fecal transplants contaminated with deadly bacterium resulted in two deaths and four hospitalizations. The six infections were caused by enteropathogenic Escherichia coli (EPEC) and Shigatoxin-producing Escherichia coli (STEC) and occurred after patients underwent fecal transplants. All six patients fell ill after undergoing fecal transplants to treat Clostridium difficile infections not responsive to standard therapies.