Klinické hodnocení transplantace fekální mikrobioty v Dětské nemocnici FN Brno
| Title in English | Clinical trial of fecal microbiota transplantation at the Children's Hospital, University Hospital Brno |
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| Year of publication | 2025 |
| Type | Requested lectures |
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| Description | Faecal microbiota transplantation (FMT) is no longer unknown in Czech hospitals – it is used to treat recurrent or refractory Clostridioides difficile infection (rCDI). This seemingly strange method is currently attracting attention in the scientific world. The transfer of biological material containing microorganisms from the stool of a healthy donor into the recipient's digestive tract can do more than just suppress C. diff. It is increasingly apparent that the microbiota influences not only the health of the digestive tract but also that of unrelated organ systems, including the brain. If a physician wants to study the effects of FMT in an indication other than r/rCDI, this must be done exclusively in a clinical study. Since the FMT preparation is considered a medicinal product by the State Institute for Drug Control and regulators in a number of other countries, any such research must take the form of a clinical trial. CZECRIN, in collaboration with the Department of Pediatric Neurology at University Hospital Brno, is currently preparing a clinical trial with FMT in pediatric patients. This presentation outlines the often humorous challenges we have had to deal with so far in planning the study, standardising production, and preparing the documentation required for the trial application. |
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