University of Kentucky College of Medcine Lexington, KY
Alden Currier, DO, Lamprinos Michailidis, MD, Deborah Flomenhoft, MD; University of Kentucky College of Medcine, Lexington, KY
Introduction: Fecal Microbiota Transplantation (FMT) has shown great efficacy in treating Clostridium Difficile infection (CDI) that is either recurrent or refractory to standard therapy, as well as other diseases that are difficult to treat. Widespread clinical acceptance has been sluggish, in part due to concerns over safety and adverse events. Recent case studies of ESBL producing E. Coli bacteremia even led the FDA to issue a safety communication. We performed a systematic review of the literature and meta-analysis of high quality, prospective randomized controlled trials of FMT utilized for various indications. We sought to identify the pooled rates of adverse events and serious adverse events as described by the authors. Methods: Electronic database search was performed for relevant studies. Studies were selected based on pre-defined exclusion criteria and assessed for quality by a validated risk-of-bias tool. Only prospective, randomized, controlled studies of high quality and adequate duration of follow up were included in the final analysis. Data was extracted on demographics, AE rates, common AEs, indication, delivery method and follow up duration. We calculated the pooled adverse event and serious adverse event rates and performed heterogeneity analysis. Results: 334 articles reviewed, nine studies with 756 FMTs performed on 388 patients were selected for final analysis. Patients were predominantly female (60.5%) with a mean age of 51.2 years. All studies were prospective, randomized control trials with low risk of bias based on independent quality assessment by two investigators. Indications for FMT were recurrent CDI, UC, IBS, and MDRO colonization. Modes of delivery varied. Mean follow up duration was 12.6 weeks (range 6- 24 weeks). Adverse events were only analyzed if they were reported per patient and deemed to be related per author definition. Pooled adverse event rate was 35.4% (95% CI: 29.5%- 41.9%; p=0.0001). Serious adverse event rate was 5.3% (95% CI: 3.1%- 8.8%; p=0.0001). Most common adverse event reported was bloating. Significant heterogeneity was observed within and across studies in the case of total AEs (Q= 100, I2= 92%) but not SAEs (Q= 7.7, I2= 0%). Discussion: There are several high-quality studies that clearly report rates of adverse events of FMT in the literature but lack standardized definitions of AE. Based on the selected studies the AE rate of FMT is 35.4% with most being mild and self-limited. The estimated rate of SAEs that are at least possibly related is 5.3%.
Inclusion and Exclusion Criteria
Serious Adverse Event Forest Plot
Disclosures: Alden Currier indicated no relevant financial relationships. Lamprinos Michailidis indicated no relevant financial relationships. Deborah Flomenhoft indicated no relevant financial relationships.