FMT is a method of treating disease by re-establishing the normal intestinal micro-ecological structure, the full name is enterobacterial transplantation. In other words, the intestinal fluids of healthy people are extracted and introduced into the patient’s intestine by means of nasal intestinal tube or gastrointestinal tube, and the beneficial bacteria in the intestine of healthy people are used to treat diseases. As an emerging technology in recent years, FMT has made breakthroughs in a variety of diseases, especially in chronic refractory diseases. What diseases are suitable for FMT treatment? Currently, FMT is used to treat diseases such as irritable bowel syndrome, ulcerative colitis, Crohn’s disease, antibiotic-associated diarrhea, chronic intractable constipation, fatty liver, chronic hepatitis B, cirrhosis, Clostridium difficile infection, and autism. What are the advantages of FMT treatment? 1, precise efficacy, high efficiency for chronic refractory diseases, i.e. those for which drug therapy or other treatment effects are ineffective. 2, few side effects, no serious complications of FMT have been reported, and no special adverse reactions have been seen. 3, short course of treatment, most diseases can be treated 1-3 times, a few chronic refractory diseases can increase the course of treatment as appropriate. 4, low recurrence rate, compared with drug treatment, the efficacy is exact and the recurrence rate is low. FDA to regulate fecal transplantation There have been many recent studies showing that treatment of drug-resistant Clostridium difficile (C. difficile) infections can be achieved through fecal transplantation. The FDA has said that fecal bacteria meet the definition of a biologic product and that an IND is required before such products can be used for human testing. The FDA said that in emergency situations, investigators can request the use of fecal transplants by phone or other rapid means of communication, to which the FDA can respond quickly. However, in non-emergency situations, a clinical study request must be reviewed by the FDA before fecal transplants can be used on an individual patient basis. Many investigators and clinicians expect that this rule will have a significant impact on their clinical practice and research. Herbert DuPont, M.D., of the University of Texas Medical Center at Houston, who is preparing a major fecal transplant program, said his research protocol has been approved by the center’s Institutional Review Board (IRB). Yes. Do I have questions about the results? Absolutely not.” DuPont, who also attended the hearing, expressed understanding that the FDA went ahead and set standards because of concerns about the safety and effectiveness of procedures such as fecal transplants. Vanderbilt University infectious disease expert and M.D. William K. Schaffner said the requirements for clinical research applications could increase the financial burden on investigators. William Schaffner told MedPage Today. Schaffner told MedPage Today, “It costs a lot of money just to prepare a clinical study application and then go out and implement it and manage the data to the level of sophistication that the FDA requires.” The FDA’s Allen said he was not aware of the cost of clinical study applications at this time, and the FDA said the purpose of a clinical study application is to ensure that patients are not exposed to any “unreasonable risk.” But the FDA also noted that regulating fecal transplant procedures is not associated with any adverse events.