Fecal transplants are used to cure hard-to-treat Clostridioides difficile (C. difficile) infections by replacing infected stool in the gastrointestinal tract with a healthy donor’s stool, which can help restore healthy gut bacteria and clear the infection. While the FDA hasn’t approved the use of fecal transplantations, it has cleared them for investigational use, and they’ve been successfully used to treat C. difficile, a potentially life-threatening infection.
In June 2019, however, the FDA put a temporary halt to fecal transplants performed in clinical trials. This occurred after two patients with weakened immune systems developed serious infections, and one died, after being given stool from a single donor, which turned out to contain a multidrug-resistant organism (MDRO), E. coli bacteria. The donor’s stool hadn’t been tested for the presence of MDROs. As a result, the FDA outlined additional protections to be implemented before doctors could resume the transplants.
Among the FDA’s updated protocols: Donor stool must be tested for MDROs, which are resistant to many antibiotics.
What you should do
The FDA recommends that anyone considering fecal transplant to treat a C. difficile infection should speak with his or her doctor to understand the potential risks associated with the procedure. Fecal transplants should be used only after all other standard treatments have failed.
This article first appeared in the September 2019 issue of UC Berkeley Health After 50.
Also see Fecal Transplants and the FDA.