Improving Clinical Outcomes of Encapsulated Faecal Microbiota Transplantation for Clostridioides difficile Infection Through Empirical Donor Selection and Optimised Dosing: A Quality Improvement Study

BackgroundFaecal microbiota transplantation (FMT) is effective for Clostridioides difficile infection (CDI), but real‐world effectiveness data are warranted to refine treatment algorithms. We previously found that FMT effectiveness varied with donors, and the effect of a single capsule FMT administration was lower than expected.AimsTo improve FMT outcomes through empirical donor exclusion and application of an optimised capsule FMT dosing regimen.MethodsIn this multi‐site Danish quality improvement study, we included patients with CDI treated with capsule‐based FMT from 24 June 2019 to 30 September 2024. The primary outcome was cure of C. difficile‐associated diarrhoea (CDAD) 8 weeks after FMT. We assessed this using statistical process control charts monitored separately for the primary FMT centre and the external FMT sites. We used multivariable, mixed‐effect logistic regression analysis to evaluate the impact of FMT dosing while adjusting for patient, donor and CDI‐related factors.ResultsWe included 1176 patients (1707 FMT treatments). At external FMT sites, the cure rate from one FMT treatment changed from 50% (95% confidence interval (CI): 45%–56%) to 59% (55%–63%) following the exclusion of three low‐performing donors in November 2022. After implementing a two‐dose capsule FMT dosing regimen in February 2024, the cure rate increased to 72% (65%–77%). The impact of the two‐dose capsule FMT dosing regimen remained statistically significant after adjustment (odds ratio 1.22; 95% CI 1.16–1.28; p < 0.001).ConclusionEmpirical donor selection and a two‐dose capsule FMT regimen improved clinical outcomes in a large‐scale system treating patients with CDI.