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

TY - JOUR

T1 - Donor, patient age and exposure to antibiotics are associated with the outcome of faecal microbiota transplantation for recurrent Clostridioides difficile infection

T2 - A prospective cohort study

AU - Baunwall, Simon M.D.

AU - Hansen, Mette M.

AU - Andreasen, Sara E.

AU - Eriksen, Marcel K.

AU - Rågård, Nina

AU - Kelsen, Jens

AU - Grosen, Anne K.

AU - Mikkelsen, Susan

AU - Erikstrup, Christian

AU - Dahlerup, Jens F.

AU - Hvas, Christian L.

PY - 2023/9

Y1 - 2023/9

N2 - Background: Faecal microbiota transplantation (FMT) is effective for recurrent Clostridioides difficile infection (rCDI), but its effect varies inexplicably. Aims: To optimise the effectiveness of FMT for rCDI and validate determinants for effect. Methods: We 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. Results: 183 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. Conclusion: FMT 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).

AB - Background: Faecal microbiota transplantation (FMT) is effective for recurrent Clostridioides difficile infection (rCDI), but its effect varies inexplicably. Aims: To optimise the effectiveness of FMT for rCDI and validate determinants for effect. Methods: We 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. Results: 183 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. Conclusion: FMT 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).

KW - CDI

KW - Clostridioides difficile infection

KW - Faecal microbiota transplantation

KW - FMT

KW - optimisation

KW - optimised use

KW - statistical process control

UR - http://www.scopus.com/inward/record.url?scp=85165451692&partnerID=8YFLogxK

U2 - 10.1111/apt.17642

DO - 10.1111/apt.17642

M3 - Journal article

C2 - 37482926

AN - SCOPUS:85165451692

SN - 0269-2813

VL - 58

SP - 503

EP - 515

JO - Alimentary Pharmacology and Therapeutics

JF - Alimentary Pharmacology and Therapeutics

IS - 5

ER -