Fecal microbiota transplantation is currently being established as a second-line treatment for recurrent Clostridium difficile infection.
Fecal microbiota transplantation is further being considered for other infectious and inflammatory conditions.
Safe and reproducible methods for donor screening, laboratory processing and clinical application of fecal microbiota transplantation are warranted.
Dr Simon Jørgensen and colleagues described the development of a complete clinical application framework for fecal microbiota transplantation.
The framework has been developed to comply with the European Tissue Act, thus considering donor feces for fecal microbiota transplantation comparable to a human tissue and not a drug.
Recruitment and screening of potential feces donors took place in the public blood donor setting and consisted of questionnaires, blood sampling and fecal sample analysis.
|Donor–recipient matching data will be maintained and secured for 30 years|
|European Journal of Gastroenterology & Hepatology|
Once approved, and following their written informed consent, the team invited eligible donors for voluntary fecal donation.
The research team report that laboratory processing protocols describe the initial handling, cryopreservation and thawing for clinical application.
The clinical fecal microbiota transplantation procedures took place in a gastroenterological setting using a nasojejunal tube or colonoscopy, and follow-ups were performed at 1, 8 and 26 weeks after fecal microbiota transplantation.
The researchers emphasized that complete traceability of essential equipment, fecal samples and donor–recipient matching data will be maintained and secured for 30 years.
Dr Jørgensen's team concludes, "A clinical fecal microbiota transplantation service should be consolidated by a complete documentation system that complies with the European Tissue Act."
"In this paper, we provide a description of such a framework."