Fecal therapy according to the standard
FDA intends to standardize intestinal flora transplantation
ABC Journal based on Nature: FDA gets to grips with faecesFor several years, doctors have resorted to intestinal microflora transplantation as a means of treating chronic inflammatory bowel diseases.
This procedure often turns out to be therapeutically successful, but so far no single protocol has been developed for its implementation and preparation of transplant material. Due to the ever-growing interest of patients in this procedure, the American Food and Drug Administration (FDA) has begun to develop a unified standard for intestinal microflora samples for transplantation.
The FDA has already accumulated a considerable number of clinical research results that have confirmed the effectiveness of transplantation in the treatment of chronic intestinal inflammation, especially caused by Clostridium difficile. This bacterium has a pronounced resistance to antibiotics and leads to the death of tens of thousands of patients annually. An analysis of the treatment of 300 patients conducted in 2011 showed that intestinal microflora transplantation cures chronic inflammation caused by C.difficile and not treatable with antibiotics in 92 percent of cases.
However, many doctors, seeing such effectiveness, try to prescribe intestinal microflora transplantation for other diseases in which its effectiveness is less proven or not proven at all. Moreover, if the intestinal microflora is not checked properly, the patient can be infected with dangerous bacteria during the procedure. Methods of preparing microflora also vary — some researchers freeze it, others believe that the material should be fresh, obtained no more than 6 hours ago. Various researchers add saline, water and even milk to the transplanted microflora.
Therefore, the creation of a single protocol for the preparation of the material and the procedure is extremely necessary. According to representatives of the FDA, the intestinal microflora in this case will be considered and regulated by the Administration as a medicinal product. The FDA also calls on all American doctors conducting this transplant to fill out a special Investigative New Drug form from now on and send it to the FDA. Within 30 days of receiving this form, the Administration reserves the right to cancel the appointment of this procedure.
The problem that the FDA is currently facing is choosing the most effective method of carrying out this procedure from all existing ones. To do this, experts will have to analyze many different protocols of the procedure and choose the most effective and safe option. It is assumed that the safest donor of intestinal microflora for a patient is a person with the same blood type and similar genetic characteristics and lifestyle.
It is possible that in the near future the Russian regulators of the pharmaceutical drugs and medical services market will face a similar problem.
Portal "Eternal youth" http://vechnayamolodost.ru19.06.2013