Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice

Abstract

ObjectiveFaecal microbiota transplantation (FMT) has proved to be an extremely effective treatment for recurrent Clostridioides difficile infection, and there is interest in its potential application in other gastrointestinal and systemic diseases. However, the recent death and episode of septicaemia following FMT highlights the need for further appraisal and guidelines on donor evaluation, production standards, treatment facilities and acceptable clinical indications.DesignFor these consensus statements, a 24-member multidisciplinary working group voted online and then convened in-person, using a modified Delphi approach to formulate and refine a series of recommendations based on best evidence and expert opinion. Invitations to participate were directed to Australian experts, with an international delegate assisting the development. The following issues regarding the use of FMT in clinical practice were addressed: donor selection and screening, clinical indications, requirements of FMT centres and future directions. Evidence was rated using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system.ResultsConsensus was reached on 27 statements to provide guidance on best practice in FMT. These include: (1) minimum standards for donor screening with recommended clinical selection criteria, blood and stool testing; (2) accepted routes of administration; (3) clinical indications; (4) minimum standards for FMT production and requirements for treatment facilities acknowledging distinction between single-site centres (eg, hospital-based) and stool banks; and (5) recommendations on future research and product development.ConclusionsThese FMT consensus statements provide comprehensive recommendations around the production and use of FMT in clinical practice with relevance to clinicians, researchers and policy makers.

Fecal Microbiota Transplantation May Be the Best Option in Treating Multiple Clostridioides difficile Infection: A Network Meta-Analysis

“…Furthermore, in its updated guidelines, the Australasian Society of Infectious Diseases recommends the use of FMT following the failure of less invasive options and claims that there are no data comparing the acceptability and effectiveness of FMT, fidaxomicin, and orally administered vancomycin for multiple CDI recurrences [21]. However, the Australian consensus statement for the use of FMT recommends it for recurrent CDI cases with a high quality of evidence [38].…”

Faecal Microbiota Transplantation is Effective for the Initial Treatment of Clostridium difficile Infection: A Retrospective Clinical Review

“…The initial infusion was administrated via colonoscopy, followed the next day by rectal enema. The regulation, production and use of fresh FMT were performed in accordance with recommendations at the time of treatment [13][14][15][16]. Donors were regularly screened and both their stool and blood were routinely tested for any pathology.…”

The future of faecal microbiota transplantation in gastrointestinal illness

“…Due to a plethora of successful research in the area, FMT is currently the recommended treatment method for recurrent Clostridium difficile infection (rCDI), with a cure rate of greater than 80-85% 7 . For the treatment of rCDI, FMT is effective regardless of the route of delivery, though lower GI delivery has demonstrated higher efficacy and less associated aspiration events; current consensus statements suggest that this should be individualized based on patient and disease characteristics, with careful consideration of the benefits and risks of each route of administration 8 .…”