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Faecal microbiota transplantation: establishment of a clinical application framework

Jørgensen, Simon M.D.a; Hansen, Mette M.a; Erikstrup, Christianb; Dahlerup, Jens F.a; Hvas, Christian L.a

European Journal of Gastroenterology & Hepatology: November 2017 - Volume 29 - Issue 11 - p e36–e45
doi: 10.1097/MEG.0000000000000958
Original Articles: Hepatitis

Background: Faecal microbiota transplantation (FMT) is currently being established as a second-line treatment for recurrent Clostridium difficile infection. FMT is further being considered for other infectious and inflammatory conditions. Safe and reproducible methods for donor screening, laboratory processing and clinical application of FMT are warranted.

Methods: Here, we describe the development of a complete clinical application framework for FMT. The framework has been developed to comply with the European Tissue Act, thus considering donor faeces for FMT comparable to a human tissue and not a drug.

Results: Recruitment and screening of potential faeces donors took place in the public blood donor setting and consisted of questionnaires, blood sampling and faecal sample analysis. Once approved, and following their written informed consent, eligible donors were invited for voluntary faecal donation. Laboratory processing protocols describe the initial handling, cryopreservation and thawing for clinical application. The clinical FMT 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 FMT. Complete traceability of essential equipment, faecal samples and donor–recipient matching data will be maintained and secured for 30 years.

Conclusion: A clinical FMT 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.

Departments of aHepatology and Gastroenterology

bClinical Immunology, Aarhus University Hospital, Aarhus, Denmark

Correspondence to Christian L. Hvas, MD, PhD, Department of Hepatology and Gastroenterology, Aarhus University Hospital, Noerrebrogade 44, Building 7, DK-8000 Aarhus C, Denmark Tel: +45 283 51839; fax: +45 784 62820; e-mail: christian.hvas@auh.rm.dk

Received May 16, 2017

Accepted July 18, 2017

Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved.