Donor, patient age and exposure to antibiotics are associated with the outcome of faecal microbiota transplantation for recurrent Clostridioides difficile infection: A prospective cohort study

Abstract

SummaryBackgroundFaecal microbiota transplantation (FMT) is effective for recurrent Clostridioides difficile infection (rCDI), but its effect varies inexplicably.AimsTo optimise the effectiveness of FMT for rCDI and validate determinants for effectMethodsWe conducted a cohort study, including all patients treated with FMT for rCDI between October 2018 and June 2020. Statistical process control was used to evaluate the impact of prospective quality improvement on the effect of single FMT treatments per 10–11 patients. Targeting an 80% effect, optimisations included changes to processing procedures, preparation and clinical application of FMT. The primary outcome was the resolution of Clostridioides difficile‐associated diarrhoea at week 8. If CDI recurred, FMT was repeated. All patients were followed for 8 weeks after their latest FMT.Results183 patients with rCDI received 290 FMT treatments. A single FMT achieved resolution at week 8 in 127 (69%, 95% CI: 62%–76%), while repeated FMT cumulatively achieved resolution in 167/183 (91%, 95% CI: 86%–95%). The single FMT effect varied between 36% and 100% over time. In a mixed‐effect model, patient age above 65 years, non‐rCDI antibiotics at week 1 post‐FMT, and donor were associated with effect. Neither increasing the dosages of faecal microbes nor standardising the processing improved outcomes.ConclusionFMT has a high cumulative effectiveness in patients with rCDI following multiple administrations, but the single FMT effect is variable and may be optimised using statistical process control. Optimising FMT by considering patient age, post‐FMT antibiotics, donor and multiple administrations may improve the treatment outcomes.ClinicalTrials.gov (Study identifier: NCT03712722).

Editorial: Continuous monitoring to improve outcome of treatment—the next step towards safe and effective faecal microbiota transplantation

“…Baunwall et al 7 have described efforts to improve the outcome of FMT facilitated by the Centre for Faecal Microbiota Transplantation (CEFTA) in Aarhus, Denmark. In a prospective cohort study including 183 patients treated between 1 October 2018 and 30 June 2020, they monitored the outcome of treatment and the effects of attempts to improve their FMT protocol using statistical process control (SPC), a quality improvement technique.…”

“…After the foreseen revision of the EU legislation on blood, tissues and cells, stool for FMT may become a transplantation product within the EU. This marks a new era for FMT, and will oblige stool banks to incorporate quality control, such as described by Baunwall et al , 7 as part of their working processes.…”