Australian consensus statements have been published for the regulation, production and use of faecal microbiota transplantation in the treatment of C. difficile and other GI disorders such as IBD.
A series of 27 recommendations have been developed by an Australian multidisciplinary working group that included gastroenterologists from the Gastroenterological Society of Australasia (GESA), clinical microbiologists, infectious diseases specialists, nurse consultant as well as patient representatives and a delegate from the Therapeutic Goods Administration (TGA).
The statements were developed based on the using the GRADE system of best evidence and expert opinion and addressed issues such as minimum standards for donor screening, clinical selection criteria, blood and stool testing and accepted routes of administration. They also provide recommendations on clinical indications, minimum standards for FMT production and requirements for treatment facilities (distinguishing between single site centres such as hospitals and stool banks).
Notably, the statements include the following recommendations that FMT may be efficacious as induction therapy in mild to moderate ulcerative colitis:.
- If FMT is used for the treatment of ulcerative colitis and there is no response or worsening of the disease, then other therapeutic options should not be delayed;
- FMT is recommended in patients with IBD with recurrent C. difficile infection (CDI);
- There is insufficient evidence for FMT in the maintenance therapy of ulcerative colitis, Crohn’s disease, pouchitis, irritable bowel syndrome, functional gut disorders, metabolic syndrome or other indications. Enrolment in clinical trials is recommended;
- For indications other than recurrent C. difficile infection and induction of remission in mild to moderate ulcerative colitis, patients should be enrolled in research studies assessing clinical and microbiological outcomes.
“These are the first consensus statements acknowledging the treatment efficacy of FMT in the induction of remission in ulcerative colitis, while highlighting the issues that still need to be clarified before it can be recommended in routine clinical practice,” said the statement authors, including gastroenterologist Professor Rupert Leong of Concord Repatriation General Hospital, Sydney.
“Our proposed screening and regulatory framework for facilities offering FMT are practical, achievable and a reasonable compromise to maintain safety while not impeding its use in clinical practice or research,” they conclude.
The statements are published in Gut.