Rules of fecal therapy
A three-stage scheme for regulating fecal transplantation has been compiled
American scientists have offered their view on the policy of regulating the process of fecal transplantation for the treatment of pseudomembranous colitis. It should combine safety, effectiveness and accessibility of treatment.
In most cases, the use of fecal transplantation is performed as an experimental treatment method, however, for the treatment of pseudomembranous enterocolitis caused by the bacterium Clostridium difficile, this operation is a standard approach to prevent relapses.
However, there is still no consensus on the regulation of fecal transplantation. In 2016, the US FDA (Food and Drug Administration) published a draft guideline according to which stool samples that a patient receives from a special bank or directly from a donor must undergo the IND (Investigational New Drug) program developed for clinical trials of experimental drugs.
However, this approach has been criticized because it creates more obstacles and costs than it benefits. The difficulty in using IND for samples of "good" feces is that they are too unlike conventional drugs: each "product" has a unique composition that is constantly changing. In addition, many types of bacteria that make up the gut microbiota are extremely difficult to cultivate in vitro.
In this regard, some experts suggest considering stool samples for transplantation as donor tissue rather than medicine, and regulate such operations accordingly.
The authors of the new work combined the opinions described above, making up a three-stage regulation scheme. According to this approach, permission for fecal transplantation operations in the treatment of pseudomembranous enterocolitis can be obtained according to a simplified scheme. Scientists propose to regulate the flow of stool samples to centralized banks according to the same criteria that donor tissues or cells undergo. But for fecal–based medicines – for example, with a slightly modified microbial composition - the authors of the work suggest applying adapted IND requirements.
The scientists presented their point of view on the regulation of the process of fecal transplantation in an article published in the journal Science (Hoffmann et al., Improving regulation of microbiota transplants).
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