Guidelines recommend fecal-microbiota transplant for recurrent or refractory C. diff

Last Updated: 2018-09-20

By Will Boggs MD

NEW YORK (Reuters Health) - 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 FMT should be administered by strictly regulated healthcare providers," Dr. Horace R. T. Williams from St. Mary's Hospital, in London, U.K., told Reuters Health by email.

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/or antitoxin therapy prior to 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.

Potential FMT donors should undergo 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 Reuters Health by email, "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.

She added, "This is a rapidly evolving area, and it is likely as new evidence emerges further indications for FMT will become apparent."

Dr. Michael H. Woodworth from Emory University, in Atlanta, Georgia, who has studied the use of FMT in recurrent CDI, told Reuters Health by email, "Studies of many other applications of FMT are underway, including for treatment of intestinal colonization with multi-drug resistant organisms, and could have significant impact on clinical practice in the near term."

"Physicians outside the U.K. should bear in mind that the specific regulatory requirements for FMT, especially for non-CDI indications, may vary and that informed consent from patients and ensuring regulatory compliance are critical to building an effective FMT program," said Dr. Woodworth, who also was not involved in the guidelines.

Dr. Monika Fischer from Indiana University School of Medicine, in Indianapolis, recently reviewed FMT for the treatment of recurrent and severe CDI in solid-organ-transplant recipients, said, "These British guidelines recommend FMT after the second recurrence or third episode - which now appears to be the standard worldwide including the U.S. - but also recommend consideration of FMT after the first recurrence if risk factors for recurrence, such as history of severe CDI, exist. The latter part is very important and should be emphasized."

"Clinicians should use centralized stool banks; it will save a lot of headaches, streamline logistics, (and it's) safer to patients and cheaper overall," Dr. Fischer, who was not involved in the guidelines, told Reuters Health by email.

SOURCE: https://bit.ly/2xD6JGP

Gut 2018.