Clinical and Safety Outcomes of FMT for Clostridioides difficile Infection in South Australia
Overview
This 10-year prospective study in South Australia evaluated fecal microbiota transplantation (FMT) for recurrent, refractory, severe, and fulminant Clostridioides difficile infection (CDI). Primary cure was achieved in 84% of cases, with a low rate of serious adverse events (3%) and no deaths attributable to FMT, demonstrating its safety and efficacy in real-world clinical practice.
Background
Clostridioides difficile infection is a major healthcare-associated infection with significant morbidity and mortality, especially in severe and fulminant cases. Recurrent CDI poses a therapeutic challenge, with increasing recurrence rates after successive episodes. FMT has emerged as an effective treatment for recurrent CDI and is recommended in guidelines worldwide. In South Australia, a centralized FMT program using prescreened donor stool has been operational since 2013, providing an opportunity to assess long-term clinical and safety outcomes.
Out of 98 potential donors, 62% passed full laboratory screening; extended-spectrum β-lactamase–producing organisms were the most common exclusion reason.
Primary cure with a single FMT was achieved in 84% of CDI cases overall, with highest success in recurrent CDI (88%) and lower rates in fulminant disease (65%).
Repeat FMT was effective in cases where initial treatment failed, achieving secondary cure in 74% of those retreated.
Serious adverse events related to FMT were rare (3%), and no deaths were directly linked to the procedure.
FMT was delivered via various routes and volumes tailored to patient needs, reflecting real-world clinical practice.
Clinical Implications
FMT is a safe and effective treatment option for recurrent and refractory CDI in routine clinical settings, supporting its continued use and integration into treatment guidelines. The lower cure rates in severe and fulminant CDI highlight the need for further research to optimize FMT protocols in these high-risk groups. Centralized donor screening and manufacturing ensure product safety and quality.
Conclusion
This large, real-world Australian cohort study confirms that FMT is a safe and efficacious therapy for managing recurrent and refractory CDI over a decade. Further studies are warranted to improve outcomes in severe and fulminant CDI cases.
References
Paramasamy et al. 2024 -- Clinical and Safety Outcomes of Fecal Microbiota Transplantation for Clostridioides difficile Infection in South Australia
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