Safety and Efficacy of Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection From An International Public Stool Bank: Results From a 2050-Patient Multicenter Cohort

Background. Clostridium difficile infection (CDI) is a public health threat, and fecal microbiota transplantation (FMT) appears to be an effective therapy. Recently, universal stool banks have emerged to enable safe and seamless access to FMT. However, there is a paucity of real-world safety and efficacy data from stool banks. Methods. Quality assurance data on CDI classification, FMT delivery modality, and clinical efficacy were consecutively collected from 482 healthcare facilities across 50 US states and 7 countries between 16 January 2014 and 12 April 2016. The primary outcome was physician-reported clinical cure as per standard of care follow-up. Safety data were assessed through mandatory adverse event (AE) reporting. Descriptive statistics and chi-square analyses for binomial variables were conducted. Results. Among consecutively collected reports, complete safety and efficacy data was returned for 2050 patients, which were included in these analyses. Overall, the clinical cure rate from physician-reported data across all delivery modalities and CDI patient populations was 84.0%. The most common indication for FMT, recurrent CDI, had an 87.0% (1150/1322) clinical cure rate by lower gastrointestinal (GI) delivery (figure 1). Across the entire cohort, 85.0% (n = 1742) of patients were treated with 250-mL lower GI delivery fecal microbiota preparation and 15.0% used 30-mL upper GI delivery fecal microbiota preparation. FMT by colonoscopy (85.8% clinical cure, n = 1441) was superior to that by upper endoscopy (74.1% clinical cure, n = 201) (P < 0.01). The relationship between fecal preparation type and efficacy was statistically significant (P < 0.05), with 85.1% efficacy for 250-mL preparations and 77.9% efficacy for 30-mL preparations. CDI classification had a statistically significant impact on the rate of clinical efficacy (figure 1). From a safety perspective, 42 AEs were reported; however, no AE was determined to be definitely related to FMT, 3 were possibly related to FMT, and 39 were not related based on National Institutes of Health criteria. Conclusion. To our knowledge, this is the largest FMT study reported, and the results suggest that in a large, real-world patient cohort that includes severe and refractory CDI patients, FMT from a public stool bank can be a safe and effective treatment for CDI not responsive to standard therapy. Disclosures. M. Osman, OpenBiome: Employee, Salary; K. O'Brien, OpenBiome: Employee, Salary; Z. Stoltzner, OpenBiome: Employee, Salary; K. Ling, OpenBiome: Employee, Salary; E. Koelsch, OpenBiome: Employee, Salary; N. Dubois, OpenBiome: Employee, Salary; M. Smith, OpenBiome: Employee, Salary; Finch: Board Member, Employee and Shareholder, Equity and Salary; Z. Kassam, OpenBiome: Employee, Salary; Finch Therapeutics: Consultant and Shareholder, Equity and Research support

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