Fecal Microbiota Transplant Decreases Mortality in Patients With Refractory Severe and Severe Complicated Clostridium difficile Infection Not Eligible for Colectomy: 2017 Fellows-in-Training Award (Colon Category)

Abstract

Introduction: In patients with severe±complicated Clostridium difficile infection (CDI) non-responsive to medical therapy, mortality approaches 80% if colectomy is not offered as salvage therapy. We aimed to examine the effect of sequential fecal microbiota transplant(s) (FMT) with selective use of oral vancomycin on hospitalization-associated mortality rates in severe±complicated CDI patients not eligible to undergo surgery due to significant medical comorbidities. Methods: We conducted a retrospective cohort study by examining the EMR and FMT database between 2009-2016 at a tertiary referral center where an inpatient FMT program was implemented in 2013. FMT has been routinely offered to all qualifying patients since Jan of 2013. Inclusion criteria were: A) severe±complicated CDI per ACG guidelines, B) no response to vancomycin after ≥ 5 days of therapy C) not eligible for colectomy due to underlying medical status per surgical consultation. We compared baseline characteristics and rates of 30-day mortality between patients who received FMT(s) and those who did not. Adjusted effect of FMT was estimated using the penalized logistic regression using the Firth's approach. Results: 32 hospitalizations with severe±complicated CDI not eligible for colectomy by the surgical team were identified; 17 patients continued medical therapy and 15 were treated with sequential FMT protocol. Of those cured by FMT, an average of 1.83±0.7 FMTs were needed. Serum albumin and WBC were comparable between groups (Table 1). Regarding prognostically important variables, patients receiving FMT were significantly older (mean 75 vs 59 years, P< 0.001) and more commonly had toxic megacolon (40.0% vs 5.9%, P< 0.033), although rates of acute kidney injury (AKI) were slightly lower (73.3% vs 100%, P=0.038) compared to patients who did not receive FMT. Importantly, patients receiving sequential FMT instead of routine medical therapy had decreased CDI-related mortality (20.0% vs 82.4%, P=0.001) and all-cause mortality (20.0% vs 94.1%, P<0.001). These results remained the same after controlling for factors that significantly differed between those who received FMT and those who did not, including age, AKI, and toxic megacolon.Table: Table. Patient Characteristics and Outcomes for Patients Hospitalized with Refractory Severe and/or Complicated CDI too Ill to be Considered for ColectomyConclusion: An inpatient FMT protocol utilizing sequential FMT decreases mortality in high-risk patients compared to routine medical therapy in patients with severe±complicated CDI who are not eligible colectomy due to poor medical status.