(ORDO NEWS) — The Australian Medicines Administration (TGA) is the first in the world to approve fecal transplant therapy. It is intended for the treatment of serious bacterial infections.
While there is a huge amount of research currently being done on faecal transplants to treat a variety of conditions (including alcoholism, obesity, skin cancer, and autism), the idea of a microbiome-modifying therapy is still in its infancy.
We all know that the trillions of bacteria living in our gut play an important role in our overall health. However, scientists do not yet know how accurately this knowledge can be translated into specific clinical treatments. A fecal transplant is one of the most promising ways.
Change of new time
A faecal transplant involves a healthy donor providing feces, which are then formed into capsules or enemas for the sick patient. The goal is to populate the gut microbiome with healthy and beneficial bacteria.
But simply taking one person’s feces and giving it to someone else is a very crude and imprecise way of modifying the microbiome.
Each donor has unique populations of microorganisms. Therefore, scientists need to come up with a way to “standardize” fecal transplants that would fit a large number of people.
It is for this reason that no regulatory body in the world has gone so far as to officially recognize faecal transplantation.
For example, the US Food and Drug Administration (FDA) informally authorizes the clinical use of fecal transplants under a provision called “applicant discretion”.
However, no company in the world is currently allowed to manufacture/develop/sell microbiome therapy.
Australia and faecal transplantation
However, things are changing rapidly. And recently, the Australian TGA approved the work of biotech company BiomeBank, which is developing a “microbiome-based therapeutic product.” It’s called BIOMICTRA.
The therapy is specifically approved only for the treatment of infections caused by the bacteria Clostridioides difficile. This bacterial infection can develop in patients after antibiotic treatment and results in severe diarrhea that can sometimes be life-threatening.
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