27.05 Fecal Microbiota Transplant Protocol Implementation: A Community-Based University Hospital Experience

R. Duarte-Chavez2, T. R. Wojda1,3, B. Geme1, G. Fioravanti2, S. P. Stawicki3  1St. Luke’s University Health Network,Division Of Gastroenterology,Bethlehem, PA, USA 2St. Luke’s University Health Network,Department Of Internal Medicine,Bethlehem, PA, USA 3St. Luke’s University Health Network,Department Of Surgery,Bethlehem, PA, USA

Introduction: Clostridium difficile (CD) is a serious and increasingly prevalent healthcare associated infection. The pathogenesis of CD infection (CDI) includes the acquisition of CD with a disruption of the native gut flora. Antibiotics are a major risk although other contributors have been identified. Management combines discontinuation of the offending agent, initiation of CD-specific antibiotic(s), probiotic use, fecal microbial transplantation (FMT), and surgery as the “last resort” option. The aim of this study is to review short-term clinical results following the implementation of FMT protocol at our community-based University hospital.

Methods: Following IRB / Infection Control Committee approvals, FMT protocol was implemented for patients with CDI. Prospective tracking of FMT procedures (Jul 1, 2015-Feb 1, 2017) was conducted using REDCap™ data capture system. Indications for FMT included: (a) ≥ 3 CDI recurrences; (b) ≥2 hospital admissions with severe CDI; or (c) first episode of complicated CDI (CCDI). Risk factors for CDI and treatment failure were assessed. Patients were followed for ≥3 months to assess cure/failure, relapse and side effects. Frozen 250 mL FMT samples were acquired from OpenBiome (Somerville, MA). After 4 hrs of thawing, the liquid suspension was applied colonoscopically, from terminal ileum to mid-transverse colon. Recorded data included disease severity (Hines VA CDI Severity Score, HVCSS), concomitant medications, number of FMT treatments, non-FMT therapies, cure rates, and mortality.

Results: Thirty-five patients (mean age 58.5 yrs, 69% female) received FMT, with primary cure in 30 (86%) cases. Within this sub-group, 2/30 (6.7%) patients recurred and were subsequently cured with long-term oral vancomycin (OV). Among 5/35 (14%) primary FMT failures, 3 (60%) were cured with long-term OV and 2 (40%) required colectomy. For the 7 patients who either failed FMT or recurred, long-term OV was curative in all but 2 cases (Fig 1). For patients with severe CDI (HVCSS ≥3), primary / secondary cure rates were 6/10 (60%) and 8/10 (80%), respectively. Patients with CCDI (n=4) had higher HVCSS (4 vs 3) and mortality of 25%. Characteristics of patients who failed initial FMT included older age (70 vs 57 yrs), female sex (80% vs 67%), severe CDI (80% vs. 13%), as well as opioid use during the initial infection (60% vs 37%) and at the time of FMT (60% vs 27%). Most commonly reported side effect of FMT was loose stools.

Conclusion: This study supports the efficacy and safety of FMT in the setting of CDI, with primary (86%) and secondary (71%) non-surgical cure rates being consistent with previous reports. The potential role of opioid use as a modulator of CDI warrants further study.