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THE SOUTH AFRICAN GASTROENTEROLOGY REVIEW 2022 | VOLUME 20 | ISSUE 1 | 15 REVIEW service’ or a ‘medicine’. The administration of FMT in capsule form will be considered a medicine (more than minimally manipulated); while administration of FMT by nasogastric tube or colonoscopy will be considered as a medical treatment (minimally manipulated) which falls under the ‘health service’ scope. The use of FMT as a medicine will require registration and will be subject to the Medicines and Related Substances Control Act 101 of 1965; while the use of FMT as a health service will fall under the tissue section in the National Health Act 9 . Implementation of an FMT programme requires three distinct parts: 1. donor recruitment and testing, 2. laboratory processing and 3. clinical application. Current use of FMT in South Africa is limited mainly due to the cumbersome, costly and drawn out processes associated with recruitment, testing and processing that currently fall under the responsibility of the treating clinician. The most successful way to implement an extensive FMT programme is to establish a faecal microbiota bank (FMB). The FMB is responsible for all donor related processes including recruitment, testing, stool processing and quality control. This allows for a readily available bank of frozen products which can be requested by the clinician when required. It is the responsibility of the FMB to ensure that a continuous supply of safe faecal microbiota donor material is available. This includes recruitment and screening of donors using a standardised screening questionnaire, blood and stool tests prior to initially accepting the potential faecal microbiota donor as well as frequent repeat donor testing to ensure that their health status does not change. The FMB is further responsible for receiving the fresh sample, processing, testing and freezing thereof. Once all the required test results are available and both donor and stool have passed the release criteria, the sample may be released 10 . It is the responsibility of the treating clinician to request the FMT sample, to perform the administration procedure and to report any adverse events to the FMB. The FMT can be administered via the upper or lower gastrointestinal tract. Delivery of the faecal suspension is often via colonoscopy, nasogastric tube or enema. FMT is generally well tolerated, with minimal adverse events, even in immunocompromised patients. The most common adverse events are nausea, bloating, abdominal cramps and diarrhoea; while the more rare but severe adverse events include upper GI bleeding, aspiration and mucosal tearing 11 . As FMT success is largely dependent on good quality donors, patient outcomes, including adverse event information, need to be supplied to the FMB. Globally, there is a movement for FMB’s to be placed within a blood service. The blood services have established systems for obtaining donations, product processing, testing, storage and release, with the appropriate quality controls and donor traceability in place. Approximately 112.5 million blood transfusions take place on an annual basis globally, with safety being an essential component 5 . Blood donors are regularly subjected to health and lifestyle questionnaires and tests, and are therefore a healthy subset of the population. In addition, blood donors are already donating blood on a non-remunerated basis, are known to be altruistic and more likely to be willing to donate stool as well. The requirements of an FMB is similar to the daily activities of a blood service, making it an ideal solution to the limiting factors of performing an FMT. In Denmark, a study was performed by contacting the general public and regular blood donors to become faecal microbiota donors. Criteria to become a stool donor are more stringent than that of a blood donor; however, blood donors had enhanced eligibility (20%) as stool donors when compared to recruited donors from general public (6-8%) 5, 12 . The main constraints of the Danish blood donors not meeting the requirements to be stool donors were allergy, high body mass index and age 13 . In South Africa, an FMB could provide a centralised, accessible, convenient and economical product that can be shipped to different centres in South Africa using the existing blood service systems and processes in place, thereby facilitating the ready use of FMT in the clinical environment for patients in both the public and private sector. References 1. Woodworth MH, Neish EM, Miller NS, Dhere T, Burd EM, Carpentieri C, et al. Laboratory Testing of Donors and Stool Samples for Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection. J Clin Microbiol. 2017;55(4):1002- 10. 2. Burke KE, Lamont JT. Clostridium difficile infection: a worldwide disease. Gut Liver. 2014;8(1):1-6. 3. Surawicz CM, Brandt LJ, Binion DG, Ananthakrishnan AN, Curry SR, Gilligan PH, et al. Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections. Am J Gastroenterol. 2013;108(4):478-98; quiz 99. 4. Freeman J, Vernon J, Morris K, Nicholson S, Todhunter S, Longshaw C, et al. Pan-European longitudinal surveillance of antibiotic resistance among prevalent Clostridium difficile ribotypes. Clinical Microbiology and Infection. 2015;21(3):248. e9-.e16. 5. Jorgensen SMD, Hvas CL, Dahlerup JF, Mikkelsen S, Ehlers L, Hammeken LH, et al. Banking feces: a new frontier for public blood banks? Transfusion. 2019;59(9):2776-82. 6. Dehlholm-Lambertsen E, Hall BK, Jorgensen SMD, Jorgensen CW, Jensen ME, Larsen S, et al. Cost savings following faecal microbiota transplantation for recurrent Clostridium difficile infection. Therap Adv Gastroenterol. 2019;12:1756284819843002. 7. Kang D-W, Adams JB, Coleman DM, Pollard EL, Maldonado J, McDonough-Means S, et al. Long-term benefit of Microbiota Transfer Therapy on autism symptoms and gut microbiota. Scientific Reports. 2019;9(1):5821. 8. Lee S, Drennan K, Simons G, Hepple A, Karlsson K, Lowman W, et al. The ‘ins and outs’ of faecal microbiota transplant for recurrent Clostridium difficile diarrhoea at Wits Donald Gordon Medical Centre, Johannesburg, South Africa. S Afr Med J. 2018;108(5):403-7. 9. Labuschaigne M, Slabbert M, Budree S, Hoosien E, Brink A, Blockman M. The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 1. A legal vacuum. S Afr Med J. 2020;110(8):812-5. 10. Nicco C, Paule A, Konturek P, Edeas M. From Donor to Patient: Collection, Preparation and Cryopreservation of Fecal Samples for Fecal Microbiota Transplantation. Diseases. 2020;8(2). 11. axter M, Colville A. Adverse events in faecal microbiota transplant: a review of the literature. J Hosp Infect. 2016;92(2):117-27. 12. Jorgensen SMD, Hansen MM, Erikstrup C, Dahlerup JF, Hvas CL. Faecal microbiota transplantation: establishment of a clinical application framework. Eur J Gastroenterol Hepatol. 2017;29(11):e36-e45. 13. Jørgensen SMD, Erikstrup C, Dinh KM, Lemming LE, Dahlerup JF, Hvas CL. Recruitment of feces donors among blood donors: Results from an observational cohort study. Gut Microbes. 2018;9(6):540-50.