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FDA warns against infections from stool transplants after death



Fecal transplants – transferring feces from a healthy person to a sick person with a compromised "microbiome" – is a new and growing treatment for a variety of diseases.

On Thursday, federal health officials announced the death of a patient following such a procedure, highlighting the risk of serious infections related to stool transplants.

"While we support this area of ​​scientific discovery, it is important to note that the fecal microbiota for transplantation is not without risk," said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research. the US Food and Drug Administration.

After reports of serious, procedure-related, antibiotic-resistant infections, the FDA wants to "alert all health professionals who administer the FMT [fecal microbiota transplant] about this potential serious risk so that they can inform their patients, "said Marks in a press release.

The fecal microbiota transplant is a still experimental procedure, not yet approved by the FDA. It has been used primarily to treat severe infections of antibiotic-resistant forms of Clostridium difficile (It's hard) bacteria.

The transplant involves taking the stool from a healthy donor and placing them in the colon of the sick patient. The goal is to help replace an unhealthy "microbiome" – the trillions of bacteria in the human gut – with a more robust, disease-fighting microbiome from the donor.

Once delivered by fecal graft, this new microbiome will repopulate the patient's microbiome with healthier microorganisms, which will effectively crowd out dangerous patients. It's hard.

Researchers are also studying the use of stool transplants to treat chronic gastrointestinal diseases such as ulcerative colitis or irritable bowel syndrome.

But each treatment carries risks and the FDA has stated that two patients who received a fecal microbiota transplant in a clinical trial had developed life-threatening infections of multidrug-resistant bacteria delivered during the transplant. One of the patients is dead.

Both patients had weakened immune systems, making them more vulnerable to multi-antibiotic-resistant germs. Thus, the FDA now requires that special tests be performed on the stool used in these procedures, to ensure that no drug-resistant bacteria are found in the given material.

In addition, when the fecal microbiota transplant is used, physicians must obtain informed consent from the patient, the FDA said. Patients should be aware of the potential risks associated with the treatment and know that the treatment is still considered experimental.

The brands pointed out that the FDA still supports research in fecal transplant therapy.

"The medical community is actively engaged in exploring the potential uses of the fecal microbiota for transplantation," he said. Although the treatment is not approved by the FDA, the agency supports the use of this treatment and seeks to "strike a balance between ensuring patient safety and facilitating access to non-proprietary treatments. approved for unmet medical needs, "said Marks.

To this end, "we will continue aggressively monitoring clinical trials to ensure that patients are protected when security issues arise," said Mr. Marks.

More information

The non-profit organization OpenBiome has more on fecal microbiota transplantation.

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