Two articles in cell journal reveal the research status of fecal transplantation in the treatment of various human diseases

February 19, 2020 / BIOON / -- many microorganisms living in the intestinal tract of the body and all of them exist in our feces In recent years, many researchers have conducted fecal microbiota transplantation (FMT, fecal microbiota Transplants) has conducted a large number of studies to determine whether it can improve the health of many patients, such as ulcerative colitis and Crohn's disease Now researchers realize that FMT may bring some risks, such as blood infection and the spread of drug-resistant strains In addition, researchers have not conducted FMT related clinical studies in humans Photo source: cc0 public domain recently published two research reports in the international journal Cell Host & microbe The researchers elaborated on how to develop safe and effective FMT therapy to treat human patients Now the FDA has stated that it intends to use FMT to treat a new trial drug for C difficile infection at its discretion, provided that the therapists obtain sufficient informed consent This means that even if the treatment is not approved, it can sometimes be used in special circumstances, without the need to submit a new trial drug application like FDA, while researchers using FMT to treat other diseases still need to submit a new trial drug to FDA At present, researchers are evaluating different preparation methods of FMT, including materials provided by self FMT and faecal bank In addition, a manufacturer is also developing new FMT technology to obtain license; researcher Kate Markey said: 'we are very pleased to have the opportunity to promote research in the field of fecal microbiological transplantation, especially where FMT may represent an opportunity to improve patient outcomes The researchers said that the method of collecting and preparing donation materials is not complicated At present, they don't know the characteristics of the best FMT materials, such as the best bacterial composition for specific results Of course, the FDA is also making continuous efforts to provide relevant donor screening and testing at the same time, said researcher Paul Carlson, although the FDA regularly holds public scientific meetings However, we hope that the forum can provide a mechanism to provide information to a wider audience; the researchers want to give an overview of FDA's regulation of transplanted fecal microorganisms, without some consideration provided by the researchers, so as to ensure the safety of patients and the viability of bacteria in the transplanted materials These considerations include the reference list of potential pathogens screened by donors, and the exclusion of donors with high risk of pathogen exposure In addition, the researchers also considered the manufacturing process and control measures, such as the need to use an anaerobic chamber to store potentially useful bacteria with high sensitivity to oxygen during the manufacturing process of FMT At present, due to the lack of FMT for the treatment of specific diseases, it is the best choice Knowledge of bacterial composition, so the loss of aerobic microorganisms in play may have a negative impact on the therapeutic effect The researchers say it is also important to set up a placebo-controlled FMT clinical trial to treat specific diseases, because it can help clarify the safety and effectiveness of the treatment and the understanding of the specific mechanism of FMT transplantation; the next step is to conduct multiple clinical trials To verify some products already on the market and still under development, with the completion of the trial, the real potential of this therapy may become very clear Finally, researcher Carlson said that although there is still a lot of work to be done before FMT therapy becomes mainstream, FDA is currently participating in and continuing to work with scientists engaged in FMT clinical trials, so as to promote FMT to be truly safe and effective for the treatment of patients with certain diseases Original source: Kate A market, Marcel R M van den brink, Jonathan U Peled Therapeutics targeting the guide microbiology: rigid pipelines for drug development, Cell Host & microbe (2020) Doi: 10.1016/j.chom.2020.01.022 Paul E Carlson Regulatory considerations for federal microbiology transformation products, Cell Host & microbe (2020) DOI:10.1016/j.chom.2020.01.018