Report on Safety and Effectiveness of Fecal Microbiota Transplantation Released

The first results from the NIH-funded AGA Fecal Microbiota Transplantation (FMT) National Registry, the most extensive real-world study on FMT's safety and effectiveness, have been released by American Gastroenterological Association (AGA).

FMT led to a cure of Clostridioides difficile (C. difficile) infection in 90% of patients across 20 North American FMT practice sites, revealed findings published in Gastroenterology.

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‘Ninety percent of patients tracked in the AGA FMT National Registry was cured of C. difficile infection with few severe side effects.’

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"While the value of fecal microbiota transplantation for treating recurrent C. difficile infection is clear from research studies, the potential long-term consequences of altering a patient's gut microbiota are not fully known," says Dr. Colleen R. Kelly, Associate Professor of Medicine at Brown University in Providence, Rhode Island and co-principal investigator of the AGA FMT National Registry. "Releasing the initial results of the AGA FMT National Registry is an important step toward understanding the true risk and benefits of microbiota therapeutics in a real-world setting."

The effectiveness and safety outcomes from the first 259 patients enrolled in the registry between December 2017 and September 2019 were analyzed.

All the participants received fecal transplantation using an unknown donor from stool banks. Colonoscopy, followed by upper endoscopy was the most common method of FMT delivery.

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99% of participants had their C. difficile infection cured, with 197 of those requiring only a single FMT.

In 11 participants, infections were reported. In only 4% of participants, FMT response was deemed durable.

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"These initial results show a high success rate of FMT in the real-world setting. We'll continue to track these patients for 10 years to assess long-term safety, which will be critical to determining the full safety profile of FMT," added Dr. Kelly.

Fecal Microbiota Transplant (FMT)

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In the 21st century, fecal microbiota transplantation (FMT) is one of the most innovative new treatments.

It is a medical procedure in which the stool from a healthy person is prepared and then put into the intestine of a sick patient. This method is used to treat C. difficile infections. Recurrent C. difficile infection is linked to morbidity and mortality and frequent failure of standard medical treatments.

Source-Medindia