New joint guidelines from the British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) support the use of fecal-microbiota transplant (FMT) as second-line treatment for recurrent or refractory Clostridium difficile infection (CDI), but not for any other indications.
"We recommend that strictly regulated healthcare providers should administer FMT," Dr. Horace R. T. Williams from St. Mary's Hospital, in London, U.K., told.
Dr. Williams and colleagues in the BSG/HIS FMT working group set out to provide best-practice recommendations for the provision of an FMT service. Their report, online August 28 in Gut, includes recommendations regarding the use of FMT for the treatment of CDI, as well as potential non-CDI indications, in adults.
The guidelines recommend consideration of FMT in patients with recurrent or refractory CDI, but not as the initial treatment. Instead, they recommend antimicrobial and antitoxin therapy before considering FMT. All FMT recipients should receive routine follow-up, and repeat FMT should be offered after initial FMT failure.
FMT should be offered with caution to immunosuppressed patients, but patients with recurrent CDI and inflammatory bowel disease (IBD) can be offered FMT with the understanding that there is a small but recognized risk of exacerbation of IBD.
Blood and stool screening
Potential FMT donors should undergo an interview, blood and stool screening, and, where possible, FMT should be sourced from a centralized stool bank from healthy unrelated donors, according to the guidelines.
Banked frozen FMT material should be favored over fresh preparations for CDI. The guidelines do not recommend FMT as a treatment for IBD or any other gastrointestinal or non-gastrointestinal disease.
Although this might be controversial, Dr. Williams said that "as yet, there is insufficient evidence to recommend FMT for clinical indications other than recurrent CDI, although promising data are emerging in certain other conditions."
The guidelines also include recommendations regarding implementation of an FMT service, including legal aspects and clinical governance, infrastructure and FMT-production quality control.
Dr. Fidelma Fitzpatrick from The Royal College of Surgeons in Ireland and Beaumont Hospital, in Dublin, Ireland, who recently reviewed European practice for CDI treatment, told, "The issue of regulation remains one that has to be teased out as FMT is neither a tissue nor a blood product. The evidence base concerning the effectiveness of FMT continues to grow, but it remains a non-regulated product, with many different versions reported."
"In Europe," she added, "the regulation of FMT is currently at the discretion of the EU member states, though in many countries no such national regulation exists. Future planned EU regulation of FMT donor material may hinder its widespread use, depending on whether it is regulated as a drug or bodily tissue."
"In the appropriate patients, FMT is life-changing – one of our first patients could not believe that she had no diarrhea the day after her FMT (the first time in months)," said Dr. Fitzpatrick, who was not involved in the guidelines.