Fecal Microbiota Transplant (FMT) for the Treatment of Clostridium difficile (C. diff.) Infection

http://www.IndyGastro.com Fecal Microbiota Transplant (FMT) for the Treatment of Clostridium difficile (C. diff.) Infection 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 C. diff. is a very serious infection, and the incidence is on the rise throughout the world. The CDC reports that approximately 347,000 people in the U.S. alone were diagnosed with this infection in 2012. Of those, at least 14,000 died. Some estimates place that number in the 30,000 to 50,000 range, if the U.S. used the same cause of death reporting methods as most of the rest of the world. Fecal transplant has also had promising results with many other digestive or auto-immune diseases, including Irritable Bowel Syndrome, Crohn’s Disease, and Ulcerative Colitis. It has also been used around the world to treat other conditions, although more research in other areas is needed. 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. Fecal Transplant is a low-cost, low-risk, highly effective treatment. It is not currently covered by most insurance companies, as it is still classified as an experimental treatment.