Posted 23 October 2013 - 02:03 PM
Fecal Microbiota Transplantation (FMT) also known as a stool transplant or simply fecal transplant is the process of transplantation of fecal bacteria from a healthy individual into a recipient. Fecal microbiota samples that have been isolated from healthy individuals are being investigated for use in the treatment of Clostridium difficile colitis. Published data from case studies suggest that the use of fecal microbiota to restore gut flora may be an effective therapy in the management of returning C. difficile infection. However, the efficacy of this intervention has not yet been demonstrated in controlled clinical trials. Such controlled trials are needed to demonstrate the safety and effectiveness of FMT products for C. difficile infection refractory to conventional therapy. FMT is also being considered as a treatment for inflammatory bowel disease, obesity, and other disorders.
In the spring of 2013, the United States Food and Drug Administration (FDA) stated that it would require FMT products to be administered under an Investigational New Drug Application (“IND”). FDA reasoned that FMT was a biologic and that requiring INDs would help to protect patients by standardizing therapy, adding oversight, and encouraging the development of reliable products.
Advocates of FMT reacted to FDA’s new requirements by highlighting the time and cost of submitting an IND. Moreover, they emphasized that requiring INDs could lead patients to resort to do-it-yourself procedures. Only a month later, FDA made an informal statement that it would exercise enforcement discretion and allow practitioners to conduct FMT procedures without INDs.
WE STRONGLY ADVISE ANYONE WISHING TO PERFORM A SELF ADMINISTERED FMT TO DISCUSS THIS WITH THEIR HEALTHCARE PROFESSIONAL BEFORE UNDERTAKING THIS KIND OF PROCEDURE.
- Nojokeibs likes this
Posted 23 August 2017 - 07:51 PM
I'm a layperson dealing with IBS-D, Chronic Fatigue Syndrome, Arthritis, and more. I've been following the microbiome research closely for the past few years while trying to find an FMT donor. I've catalogued a bunch of information on FMT here that I keep updated: https://www.reddit.c...iome/wiki/index
Hope it helps!
What I've found to be effective: http://www.ibsgroup....working-for-me/
Starting guide to probiotics: http://HumanMicrobio...Probiotic-Guide