RECOMMENDATIONS ON THE SAFETY AND QUALITY OF FECAL TRANSPLANTATION IN HUMANS ‐ SCIENTIFIC ADVISORY BOARD REPORT ON PUBLIC HELATH POLICY ISSUED BY THE SUPERIOR HEALTH COUNCIL (SHC) OF BELGIUM (*)
Authors: Ectors Nadine 
Published: July 2016

Alterations of the human microbiota, and thus potential treatment through fecal transplantation, have been linked to a number of medical conditions. Today, convincing scientific evidence has only been reached for Clostridium difficile infections. Other clinical indications are still under investigation. There are no clear‐cut contra‐indications for the application of fecal material transplantation, the risk should be assessed on an individual basis in comparison with the potential advantages. Diminished immune status, important food allergies, … should be taken into consideration. The decision should be reached based on the preference of the treating physician after discussion with the patient. The treating physician should be a gastroenterologist or pediatrician with expertise in gastroenterology and/or a specialist in infectious diseases. When severe complications (toxic megacolon) a surgeon can be consulted. The decision should be documented.

Standardization of the procedure is mandatory. Donor selection should be based on a precise analysis of the clinical information, serology, control of a fecal sample and microbiological testing. The potential donor must be informed and sign an informed consent form. The quality and safety measures are also applicable to the potential receptor. Similarly a thorough analysis of the clinical data and serological data should be performed. The potential receptor too must be informed and sign an informed consent form. Technical aspects of this procedure are dependent on the anatomical approach (need for bowel preparation, preparation of the suspension, …). Procedures should be standardized, controlled and validated.

As well the donor as the receptor should be subjected to a medical follow‐up. Serious adverse reactions and events should be notified. Traceability and the reporting of serious adverse reactions and events apply also to the donation, procurement and testing. A centralized epidemiological follow‐up would be of interest in order to generate additional data. Donation and transplantation should be performed under adequate circumstances and potential contamination of the fecal material and suspension should be avoided by working under controlled air flows (Laminar air flow in background D). Both donor and receptor should receive psycho‐social support. All persons involved in the execution of the procedure should be adequately trained. The SHC favors centralization of the fecal material in dedicated structures in order to promote safety (traceability) and quality and to achieve guaranteed availability. These dedicated structures should be compliant to criteria.

The “status” of fecal material transplantation has been a matter of discussion in different countries over time. One could argue that fecal material could be considered to be an ATMP (advanced therapy medicinal product) subjected to the medicinal drug legislation or as human tissues and cells – bodily materials subjected to the tissue legislation. Based on the actual scientific knowledge and clinical applications, the exiting legislation and the study of the situation in other countries the SHC does regard fecal material as a bodily material (human tissues and cells). Therefore the specific legislation, quality standards and controls do apply. The application field of the Belgian law (19 December 2008) does need to be adapted to include fecal material.

In the future fecal microbiota may have to be considered as a medicinal drug depending on the application forms, the specificity of the active component or the form of the industrial preparation. Today this is not the case.