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 was consecutively collected from 482 healthcare facilities across 50 U.S states and 7 countries between January 16, 2014 and April 12, 2016. The primary outcome was physician-reported clinical cure as per standard of care follow-up. Safety data was assessed through mandatory adverse event (AE) reporting. Descriptive statistics and Chi-square analysis for binomial variables was conducted.
Results: Among consecutively collected reports, complete safety and efficacy data was returned for 2,050 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 250mL lower GI delivery fecal microbiota preparation (FMP) and 15.0% used 30mL upper GI delivery FMP. FMT by colonoscopy (85.8% clinical cure, n=1441) was superior to 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 250mL preparations and 77.9% efficacy for 30mL 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 AEs were determined to be definitely related to FMT, 3 were possibly related to FMT and 39 not related based on NIH criteria.
Conclusion: To our knowledge, this is the largest FMT study reported, and suggests 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.
Z. Stoltzner, OpenBiome: Employee , Salary
K. Ling, OpenBiome: Employee , Salary
E. Koelsch, OpenBiome: Employee , Salary
N. Dubois, OpenBiome: Employee , Salary
A. Khoiri, None
K. Amaratunga, None
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