Fekální bakterioterapie - metoda, transplantace, nebo podání léčivého přípravku?
| Title in English | Faecal microbiota transplant - treatment method, transplantation, or administration of medicinal product? |
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| Authors | |
| Year of publication | 2024 |
| Type | Conference abstract |
| MU Faculty or unit | |
| Citation | |
| Description | In many Czech hospitals, fecal bacteriotherapy (FBT) is used in the treatment of recurrent or refractory Cl. difficile infection (rCDI) in accordance with current guidelines. However, microbiota modification is also an attractive research topic. If an investigator wishes to study the effects of FBT in patients in an indication other than rCDI, this must be done exclusively in the context of a clinical trial. Currently, most national drug regulators, including the Czech SÚKL, consider FBT as a drug administration. Therefore, a clinical study with FBT in the Czechia must be approved as a clinical trial. This paper presented the requirements of the current legislation for clinical trials with FBT. |
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