June_New Drugs|Microbiome therapy is back in the spotlight with FDA approval of new oral bacterial drug
It is important to create healthy "good bacteria"! Therapeutic microbiome back in the spotlight
The intestinal tract and intestinal flora are considered as the second brain and the second genome of the human body. The intestinal bacteria affect the brain and even the whole body through the cerebral-intestinal axis, and the "bacteria-intestinal-brain axis" is based on the roles of intestinal bacterial metabolites (neurohormones), the vagus nervous system (neurotransmitters), the intestinal immune system, and the HPA axis (hypothalamus-pituitary-gland-adrenal gland), which reveal that the microflora affect the metabolic, immune, and neurological health of the body, either directly or indirectly. Although probiotic supplementation has become an important part of modern health care, it is still considered a health food rather than a therapeutic pharmaceutical product. In medicine, although intestinal flora reconstruction (or fecal microbiota transplant, FMT) is a more mature treatment, there is no US FDA-approved product on the market (Remarks: Probiotics are used as live biotherapeutic products (LBP), except for vaccines). (Note: the use of probiotics as active biotherapeutic products (live biotherapeutic products (LBP), except for vaccines), because the mechanism of microbial therapy is still unclear and controversial, so there has been no translation of the medical products used for treatment for a long time, the use of specific bacterial flora for the treatment of specific diseases of the microbiome treatments (microbiome treatments) has always been a cold medical field, but with the approval of the FDA to market the live oral bacterial drugs, the microbiome treatment has once again become the market chase! However, with the FDA's approval of new oral bacterial drugs, microbiome therapy has once again become the focus of market pursuit, symbolizing the opportunity for microbiome to move toward clinical therapeutic applications, and unveiling the prelude to the research and development of new microbiome drugs.