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Real-World Effectiveness of Faecal Microbiota Transplantation (FMT) for First or Second Clostridioides Difficile Infection (CDI): A Cohort Study
148 Pages Posted: 19 Dec 2023
More...Abstract
Background: Clostridioides difficile infection (CDI) is associated with high mortality. Faecal microbiota transplantation (FMT) is an established treatment for recurrent CDI, but its use for first or second CDI remains experimental. We investigated the effectiveness of FMT for first or second CDI in a real-world clinical setting.
Methods: This multi-site Danish cohort study included patients with first or second CDI treated with FMT from June 2019 to February 2023. Follow-up concluded on 31 August 2023. Outcome data were retrieved from electronic medical records. The primary outcome was cure of C. difficile-associated diarrhea (CDAD) eight weeks after the last FMT treatment. Secondary outcomes included CDAD cure one and eight weeks after the first FMT treatment and 90-day mortality following positive C. difficile test.
Findings: Of 517 patients evaluated for eligibility, 467 patients were included with 187 patients (40%) having their first CDI. The median patient age was 73 years (interquartile range (IQR) 58-82 years). Notably, 167 (36%) had antibiotic-refractory CDI, and 351 (75%) suffered from severe or fulminant CDI. Following the first FMT treatment, cure of CDAD was achieved in 353 patients (76%, 95% confidence interval (CI) 71-79%) at week one. At week eight, 255 patients (55%, 95% CI 50-59%) maintained sustained effect without further treatment. In patients without initial effect, repeated FMT treatments led to an overall cure of CDAD in 367 patients (79%, 95% CI 75-82%). The 90-day mortality was 10% (95% CI 8-14%).
Interpretation: Repeated FMT treatments demonstrate high effectiveness in managing patients with first or second CDI, potentially reducing mortality. These findings suggest that forwarding FMT in CDI treatment guidelines could improve patient survival.
Funding: Innovation Fund Denmark (j.no. 8056-00006B)
Declaration of Interest: We declare no competing interest.
Ethical Approval: All patients provided written informed consent for transfer of intestinal-related health information from their electronic medical records. Inclusion in this cohort did not affect patient treatment. This study was approved by the hospital boards of the participating hospitals and was registered in the Central Denmark Region Study registry (j.no.1-16 02-224-16).
Keywords: Clostridioides difficile, diarrhea, faecal microbiota transplantation, FMT
Suggested Citation: Suggested Citation