Real-world data from AGA registry shows FMT highly effective for CDI
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A prospective real-world study showed fecal microbiota transplantation was highly effective for Clostridioides difficile infection and had a good safety profile, according to new data published in Gastroenterology.
“We anticipate adding registry sites within the next 6 months, which will increase the number, as well as geographic and demographic diversity, of participants recruited,” Colleen R. Kelly, MD, FACG, from the department of medicine at Warren Alpert Medical School of Brown University, and colleague wrote. “Obtaining information on current FMT methods in North America is an important first step in characterizing FMT practice with the future goal of standardizing and optimizing FMT.”
They added, “In addition, several gut microbiota-derived products are in late phases of clinical development and likely will be approved for use in the near future. These products are hoped to reduce concerns regarding donor screening and infection transmission, but their real-world safety and effectiveness will be important to determine.”
Kelly and colleagues identified 259 patients with FMT from 20 sites enrolled in the American Gastroenterological Association FMT National Registry. Among these patients, 222 completed 1-month short-term follow-up and 123 completed 6 months of follow-up. Investigators entered into an online platform data that included FMT protocol, baseline patient characteristics, C. difficile infection cure and recurrence, and short and long-term safety outcomes.
All patients received FMT for C. difficile infection. Donors were unknown in 249 cases. Investigators reported that 1-month cure occurred in 200 patients; 197 of whom received a single FMT.
According to researchers, 112 patients with initial cure were followed to 6 months and four of these patients experienced CDI recurrence. Within 1-month of FMT, severe symptoms reported included diarrhea and abdominal pain. Three patients were hospitalized, possibly due to FMT. At 6 months, two patients received a new diagnosis of irritable bowel syndrome and two received a new diagnosis of inflammatory bowel disease.
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FMT appears highly effective in the real world for recurrent C. diff. This study showed, in the intention to treat analysis, a cure rate of roughly 86%, representing 224 of 250 patients. Moreover, FMT appears to be relatively safe, with the most common symptoms reported being diarrhea, abdominal pain, bloating and constipation. Most of these adverse events did not reach a level severe enough to require intervention. The study did report procedure-related complication. Lastly, if we are looking at adverse events after six months following FMT, there were very few serious infections and the hospitalizations reported do not appear to be related to FMT.
One of the limitations during this trial was that most of the data presented was through self-report and almost all patients received FMT from an unknown donor, most from a stool bank.
Long-term data, including data at 6 months, was not reported for most of the FMT recipients in the paper and the authors did mention that as a salient limitation.
It’s remarkable looking at the figures that they provided. It looks like most of the FMTs were in the northeast, two states in the Midwest and in the West along with Texas and Florida, which may be related to the people who are reporting to the registry. This map will continue to evolve as more and more providers increase their use of FMT as a modality.
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