Fecal microbiota transplantation: from the raw material to the pharmaceutical preparation
Fecal microbiota transplantation consists of introducing a preparation made with stool from a healthy donor into the digestive tract of a recipient with an imbalance of the intestinal microbiota (dysbiosis), in order to restore its microbial biodiversity. In France, this preparation is considered as a drug by the National Agency for the Safety of Medicines and Health Products and must be carried out under the responsibility of a pharmacist of a health facility.
Numerous clinical studies have demonstrated its efficiency in the treatment of recurrent Clostridium difficile infections, conferring to this technique a high level of clinical evidence justifying its place in many national and international recommendations as an alternative to antibiotics.
The raw material used for this preparation is of complex composition and variable depending to the donations and must be subject to all the necessary controls to eliminate the risk of transmission of known pathogens to ensure the safety of the recipients.
The preparation can be made extemporaneously or frozen for later use, and packaged in several pharmaceutical forms allowing inoculation according to different administration routes.
All pharmaceutical operations (preparation, labelling, quality control, release, storage and distribution) and the complete donor’s blood and stool results must be recorded in a batch file to ensure traceability of the preparation. A sample of the raw material and the final preparation, stored at -80° C, should be constituted as well as a donor / recipient register to assess the liability for possible side effects.
No conflict of interest related to the topic