Methods:Donors were selected using a 178-point clinical assessment and 30 laboratory investigations for infectious and microbiome-mediated diseases where only 2.8% of candidate donors qualify. Among selected donors, fecal microbiota preparations (FMPs) were produced according to standard FMP manufacturing practices. Donor-specific units were tracked by a quality assurance (QA) system that linked to de-identified individual patient outcomes. QA data was consecutively collected from 482 healthcare facilities across 50 states and 7 countries between January 16, 2014 and April 12, 2016. Donors were included if their material was used in over 10 reported patients over the study period. The primary outcome was physician reported clinical cure as per standard of care follow-up. Descriptive statistics and Chi-square analysis was conducted.
Results:Overall, 28 donors (Figure 1) were used in 1999 patients. Overall, the clinical cure rate from physician-reported data across all 28 donors was 84.4% with a range of 69.2-95.2% (Figure 2). One outlier donor was found to have a statistically significant lower clinical cure rate (70.9%, p=0.05). However, upon sensitivity analysis, the lower efficacy was driven by one site (overall clinical cure for all donors at site of 50.7%, p<0.05) and the reduced clinical cure rate was not seen across other hospitals that the donor's material was used. Otherwise, there was no statistically significant differences between donor FMT material and clinical cure for CDI not responsive to standard therapy.
Conclusion:To our knowledge, this is the largest study assessing clinical efficacy for FMT in CDI by donor and suggests it is unlikely that different donors have an impact on efficacy.
K. O'brien, OpenBiome: Employee , Salary
K. Ling, OpenBiome: Employee , Salary
E. Koelsch, OpenBiome: Employee , Salary
N. Dubois, OpenBiome: Employee , Salary
K. Amaratunga, None
M. Smith, OpenBiome: Employee , Salary
Finch Therapeutic: Board Member , Employee and Shareholder , Equity and Salary
Z. Kassam, OpenBiome: Employee , Salary
Finch Therapeutic: Consultant and Shareholder , Equity and Research support