841. Donor efficacy in fecal microbiota transplantation for recurrent Clostridium difficile: Evidence from a 1,999 patient cohort
Session: Oral Abstract Session: Clostridium difficile
Thursday, October 27, 2016: 2:45 PM
Room: 388-390
Background: Recurrent Clostridium difficileinfection (CDI) is a public health challenge and fecal microbiota transplantation (FMT) has emerged as an effective therapeutic option. Although FMT is used for treating recurrent CDI, there is no robust evidence evaluating if different donors have an impact on the clinical cure rate. We aim to evaluate if there are differences in FMT efficacy for CDI between donors from a public stool bank.

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.

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Majdi Osman, MD MPH1,2, Zachery Stoltzner, BS2, Kelsey O'brien, MPH2, Kelly Ling, BS2, Emily Koelsch, RN BSN2, Nancy Dubois, MSN MBA2,3, Kanchana Amaratunga, MD MPH4, Mark Smith, PhD2 and Zain Kassam, MD MPH2, (1)Harvard Medical School-Boston Children's Hospital, Boston, MA, (2)OpenBiome, Medford, MA, (3)William F. Connell School of Nursing, Boston College, Chestnut Hill, MA, (4)The Ottawa Hospital, Ottawa, ON, Canada


M. Osman, OpenBiome: Employee , Salary

Z. Stoltzner, OpenBiome: Employee , Salary

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

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