Fecal transplants involve the transplantation of fecal bacteria from one individual to another.
In a bulletin that will make many people do a double-take, the Food and Drug Administration just issued a very serious warning for individuals considering a controversial treatment where one individual's poop is transplanted into another.
But on Thursday federal health officials announced that a patient died after such a procedure, highlighting the potential for severe infections linked to fecal transplants. "After these adverse events occurred, stores preparations of FMT from this stool donor were tested and found to be positive for ESBL-producing E. coli identical to the organisms isolated from the two patients".
"This was a small trial, but the results suggest that faecal microbiota transplantation may be an alternative to antibiotic therapy in primary C. difficile infection", the authors wrote. In a guidance document, the FDA indicated that it would only ask investigators to discuss potential risks of the procedure as a C. difficile treatment and obtain informed consent. His writing has appeared in numerous Canada's most respected and credible publications, including the Toronto Star, CBC News and on the cover of Smithsonian Magazine. This resulted in the Food and Drug Administration halting a number of clinical trials until researchers can prove that they have procedures in place to screen donated stools for risky bacteria, stated Dr. Peter Marks, the director for the agency's Center for Biologics Evaluation and Research. The idea behind fecal transplant is to use stool from a donor who is healthy to help restore the normal balance of good gut bacteria and other organisms in the intestine.More news: Redmi K20 Launched in Europe as Xiaomi Mi 9T
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"The medical community is actively engaged in exploring the potential uses of fecal microbiota for transplantation", he said. In light of the recent patient's death, the FDA said more work needs to be done before it will expand the use of fecal transplants in research and clinical practice. The FDA said it was halting fecal transplant clinical trials until researchers can prove to the FDA that they have measures in place to verify the fecal matter is free of deadly bacteria.
Donor screening with questions that specifically address risk factors for colonization with MDROs, and exclusion of individuals at higher risk of colonization with MDROs.
The drug-resistant E.coli strain found in the patient who died matched with the strain found from the donor.