[ad_1]
An aesthetically unpleasant but really promising medical treatment – a stool graft – may involve more serious risks than expected. This week, the Food and Drug Administration issued a treatment warning after receiving reports of two people with serious drug-resistant infections as a result of the procedure. A patient finally died.
Fecal transplants, or fecal microbiota transplants (FMTs), have been explored as a means of restoring the delicate bacterial environment of the gut. The intestinal microbiome of the recipient is cleaned as much as possible with potent antibiotics, and then the donor's intestinal bacteria is transplanted, which hopefully will again seed a healthy balance of bacteria. Most FMTs are performed via an enema, although doctors are investigating whether an oral gut bacterium capsule can work as well.
It is thought that an imbalance of the intestinal microbiome contributes to conditions such as irritable bowel syndrome, inflammatory bowel disease (IBD) and perhaps even metabolic diseases such as obesity . So far, however, the most obvious potential for TMF is for people with recurrent, often excruciating, Clostridium difficile, or C. diff. Recurring cure rate C. diff with FMT have oscillated as high as 90 percent in small tests.
Why does coffee make us poop? Scientists gave coffee to rats to find out
A lot of the usual coffee drinkers know that coffee is not only great for waking them up …
Read more
FMT at this stage is an experimental treatment, however. And trials are still under way to try to find a way to make the procedure as efficient and safe as possible. According to the FDA, both superbug infections have been spotted during one such test.
The patients were part of an experimental trial on the FMT and received a transplant from the same donor. Shortly after, they developed an invasive infection caused by multidrug resistance. Escherichia coli (E. coli). Despite the efforts of the doctors, one patient did not succeed. Subsequently, the remaining samples of the donor were tested and the same E. coli the strain was discovered.
"The FDA informs members of the medical and scientific community and other interested parties of the potential risk of transmission of [multidrug-resistant organisms] FMT and the serious side effects that can result, "said the agency in its communication on safety.
It is likely that the pre-existing medical condition of both patients contributed to the severity of their illness, as their immune system was weakened. But infections could have been avoided if the doctors participating in the trial first looked for these bacteria in donors, the FDA said.
In 2013, as the FMT's trials began to start, the agency announced that it would take a non-interventionist approach to regulate its early use for C. diff infections (typically, any new drug or treatment for a disease must go through a lengthy process of FDA approval before it can be widely available). As long as patients are informed by the doctors of the potential risks and the experimental nature of the treatment, it would be less strict to approve or supervise new clinical trials. However, as a result of these tragic cases, the agency now requires all experimental trials to pre-emptively research risk factors that would make them more susceptible to acquiring superbugs, and to test their donor samples for detect the presence of this bacteria. Doctors must also inform their volunteers of these serious risks, now discovered.
"Today's safety communication stresses the importance of in-depth study of new treatments to ensure that the benefits of their treatment outweigh the risks for patients, and we will continue to monitor aggressively clinical trials to ensure that patients are protected in the event of a safety problem, "said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement from the FDA.
[ad_2]
Source link