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As a result, the agency stops several clinical trials until the researchers who lead them can demonstrate that they have in place procedures for detecting dangerous organisms in the stool data, said Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research. . He did not specify how many trials would be suspended, but clarified that it was "not a few".
Feces grafts are increasingly used to treat serious intestinal disorders, particularly an infection caused by a bacterium called Clostridium difficile, which can be fatal and tends to occur in hospitalized patients who have been heavily treated with antibiotics. . The idea behind the transplant is to use the stool of a healthy donor to restore the normal balance of bacteria and other organisms in the intestine, the microbiome.
In some cases, the transplants worked quickly and saved the lives of patients who were dying with uncontrollable diarrhea. But the procedure is not approved by the FDA and is considered experimental.
In the new cases reported, the immune system of both patients was already compromised at the time of the transplant, the FDA announced. The agency would not explain why they were immunocompromised, why they had received the transplants, who had performed the procedures or when and where the cases had occurred.
Both transplants came from feces of the same donor. The report does not indicate whether the faeces were administered in liquid form by infusion into the digestive tract or swallowed in the form of pills.
Other samples from the same donor were tested after patients became ill. The samples contained the same dangerous germs found in patients called multidrug-resistant organisms. It was an E. coli bacterium that produced an enzyme called extended spectrum beta-lactamase, which makes them resistant to several antibiotics. Stool was not tested for germs before being administered to patients.
On Thursday, the FDA warned researchers that stool from donors in fecal transplant studies should be sought for drug-resistant microbes and not be used if they were present. It also warns patients that the procedure may be risky, that it is not approved by the agency and that it should only be used as a last resort when C. difficult does not respond to standard treatments.
Marks said the agency was trying to strike a balance between giving patients who needed treatment while putting up safeguards to protect them from infection. In a statement, he said, "While we support this area of scientific discovery, it is important to note that the fecal microbiota for transplantation is not without risk."
Patients received treatment as part of a clinical trial and the researchers who conducted the test reported these cases as adverse events for the FDA, which they were required to do. But the rules governing this type of experience preclude the FDA from revealing details about the treatment or who provided it.
This article originally appeared in The New York Times.
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