FMT registry will monitor safety

IBD

16 Aug 2016

The first national registry assessing short and long-term patient outcomes associated with faecal microbiota transplantation has been launched.

Set up by the American Gastroenterological Association the Registry will allow researchers to identify potential short-term adverse outcomes and to search for long-term safety concerns.

According to the organisation the early adoption and growing enthusiasm for FMT in clinical practice in the US has outpaced scientific study, resulting in a lack of understanding of the potential health risks from human-to-human transfer of stool.

“We are in a unique position in which the responsibility to protect the safety of patients receiving FMT is combined with the opportunity to gain tremendous new insights into the biology of the human gut microbiome,” said Timothy C. Wang, MD, AGAF, president of the American Gastroenterological Association.

“AGA is eager to put a formal infrastructure into place for physicians and patients to report information that will standardise best practices for FMT, while offering insight into the gut microbiome and its role in human health and disease.”

The AGA Fecal Microbiota Transplantation National Registry will prospectively enroll patients who undergo FMT at sites throughout the U.S and will collect information on FMT methodology, FMT indication, as well as baseline data on donors and recipients.

Patients will be followed at regular intervals for up to 10 years after FMT for pre-defined and spontaneously reported adverse events and for pre-defined outcomes of effectiveness.

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