Ten-Year Follow-Up of Patients Treated with Fecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection from a Randomized Controlled Trial and Review of the Literature

Abstract

Fecal microbiota transplantation (FMT) has become a well-established treatment for recurrent Clostridioides difficile infection (rCDI). While short-term outcomes and adverse events relating to FMT have been well documented, there still is a paucity of data with regard to long-term safety. In this report, we describe the long-term follow-up of the prospective cohort of the first randomized controlled trial of FMT for rCDI, and review the existing literature. A total of 34 patients were treated with FMT for rCDI. Seven patients were still alive after a follow-up of more than 10 years and three patients were lost to follow-up. None of the 34 patients had experienced a new-onset autoimmune, gastrointestinal, or malignant disorder during follow-up. We did not find any deterioration or amelioration of pre-existing medical conditions. Furthermore, no deaths directly attributable to FMT could be identified. These findings are in accordance with the data in available literature. In conclusion, no long-term adverse events or complications directly attributable to FMT were found in our prospective cohort. Review of the available literature does not point to long-term risks associated with FMT in this elderly population, provided that carefully screened fecal suspensions are being used. No firm conclusion on the long-term safety of FMT in younger patients could be drawn.

The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridioides difficile infection and other potential indications: second edition of joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

“…60 One study 64 reported that there was a slightly higher incidence of myocardial infarction in FMT group compared with non-FMT at 1 year follow-up, but that the incidence of other conditions was similar. At 10-year follow-up, one study 65 reported that there were no new diagnoses of autoimmune diseases, gastrointestinal disorders or malignancies and that there were no deaths which were attributed to FMT.…”

The potential utility of fecal (or intestinal) microbiota transplantation in controlling infectious diseases

“…29 However, reassuringly, no significant delayed complications or adverse effects related to infections have been described in longitudinal studies looking at long term follow up of patients who have received FMT administration. 30–32 …”

Intestinal Microbiota in Common Chronic Inflammatory Disorders Affecting Children

“…This method reduces intestinal inflammation, as demonstrated by decreased levels of proinflammatory cytokines such as TNF-a, IL-1b, and interferon-g (IFN-g), and helps in restoring the intestinal homeostasis. It has been successfully used for treating recurrent and antibiotic-refractory C. difficile infections (107)(108)(109)(110), even in pediatric patients (111).…”