Short-term and long-term follow-up after faecal microbiota transplantation in patients with Clostridioides difficile

Faecal microbiota transplantation (FMT) is a highly effective therapy for recurrent Clostridioides difficile infection (rCDI). There is also significant evidence that FMT is safe in the short-term, but data on long-term safety are still emerging. This study aims to explore and describe long-term safety data in a cohort of patients who received FMT for rCDI and to evaluate the efficacy at 8 weeks follow-up. METHODS: Between October 2020 and August 2022, we carried out a prospective cohort study of patients undergoing FMT for rCDI. Data on demographic and comorbidities were recorded at baseline. Then, patients were contacted 2 weeks, 2 months, 6 months (short-term follow-up), and 1-year after FMT (long-term follow-up). At each time point, symptoms and new medical diagnoses of patients were collected. Treatment success was defined as a clinical cure 8 weeks after FMT with the absence of diarrhoea and with no recurrence. RESULTS: A total of 69 patients underwent FMT. The mean age was 68 years (range, 18–94 years old), and 34 patients (49,3%) were women. Patients underwent repeated FMT in case of failure or recurrence after the first infusion or severe clinical picture including the presence of pseudomembranous colitis. Specifically, 45 patients received a single FMT (65,2%) 18 patients received a second infusion (26%), four patients received three infusions (5,8%), one patient received four infusions (1,44%), and another patient received a sixth infusion (1,44%). At the end of the follow-up, 7 patients (10,15%) died due to causes not directly attributable to FMT, as evaluated by the experts. None of the 69 patients received a new diagnosis of autoimmune, gastrointestinal, or malignancy during follow-up. The cure rate at 8 weeks was calculated in 66 patients (3 were lost at 8 weeks follow-up) treated by single and multiple infusion and was around 86,36% (n=57). CONCLUSION: In our cohort of patients with rCDI, FMT appeared to be a safe procedure in short and long terms follow-up with a low risk of transmission of infections. In conclusion, no long-term adverse events or complications directly attributable to FMT were found in our prospective cohort, but an extension of monitoring could be interesting.