Fecal Microbiota Transplant
Fecal Microbiota Transplant (FMT) is a
procedure in which fecal matter, or stool, is collected from a tested
donor, mixed with a saline or other solution, strained, and placed in a
patient, by colonoscopy, endoscopy, sigmoidoscopy, or enema.
The purpose of fecal transplant is to replace good bacteria that has
been killed or suppressed, usually by the use of antibiotics, causing
bad bacteria, specifically Clostridium difficile, or C. diff., to
over-populate the colon. This infection causes a condition called C.
diff. colitis, resulting in often debilitating, sometimes fatal
diarrhea.History of FMT
Fecal transplant was first documented in 4th century China, known as “yellow soup”.
It has been used for over 100 years in veterinary medicine, and has been used regularly for decades in many countries as the first line of defense, or treatment of choice, for C. diff. It is customary in many areas of the world for a newborn infant to receive a tiny amount of the mother’s stool by mouth, thought to provide immediate population of good bacteria in the baby’s colon, thereby jump-starting the baby’s immune system.
Fecal transplant has been used in the U.S., sporadically since the 1950′s, without much regulation. It has gained popularity in the U.S. in the past few years, although experts estimate that total number of treatments to date in the U.S. remains below 500 patients.
In late spring of 2013, the FDA announced it was classifying fecal matter as both an Investigational New Drug (IND) and a Biologic, and that only physicians currently in possession of an approved IND application would be allowed to continue performing fecal transplant.
This resulted in less than 20 physicians in the U.S. being allowed to perform fecal transplant. There was a groundswell of opposition from physicians and patients, and on June 17th, 2013, the FDA reversed their position, and announced that qualified physicians could continue to perform FMT for recurrent C. diff. only, with signed consents from patients and tested donor stool.
This has resulted in more and more physicians beginning to perform fecal transplant, but there are still only limited numbers serving the large population needing the treatment. There are also many patients who do not have a donor to assist them.
And there are many patients who have never even heard of this treatment, even though the success rate for treatment of recurrent C. diff. is estimated to be well over 90%.
In all documentation, dating back to 4th century China, there has never been a single , serious side effect reported from fecal transplant. Source FMT Foundation
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