FDA issues fecal transplant guidance

The U.S. Food and Drug Administration (FDA) has issued a guidance note about fecal transplants. A fecal transplant involves transferring the stool of a healthy person into the gut of someone with an antibiotic resistant microbe infection.

Fecal transplants (or 'fecal bacteriotherapy') appear to have a high success rate. The technique aims to restore the balance between good bacteria and bad bacteria in the colon.

The success rate was studied recently in the New England Journal of Medicine, where the process was concluded to be successful in curing 15 out of 16 patients suffering from a recurrent diarrheal infection of the problem microbe Clostridium difficile. This bacterium is one of the so-called problem bacteria, noted for being resistant to many antibiotics.

To work, the technique requires fecal matter to be transferred to the patient being transplanted through a series of enemas. With the New England study, the transplants were compared with administrations of the he antibiotic vancomycin, and the transplants worked more effectively.

In light of the success rate, the Digital Journal reported that the the American Gastroenterological Association regards fecal transplants as "a promising treatment.".

Given that fecal transplants are being tried more often, the U.S. FDA has decided that the transplants require review and regulation. The FDA has declared that fecal transplants meet the definition of a biologic therapy. This means that researchers who want to perform the procedure will now have to submit an investigational new drug (IND) application, via the FDA. To aid medics, the FDA this week released a guidance note.

One stipulation that the FDA requires is that the treating physician obtains adequate informed consent from the patient or his or her legally authorized representative before therapy begins.

Posted by Tim Sandle