World Congress at ACG2017

Simultaneous Plenary Session 4B: Esophagus / Colon

65 - Fecal Microbiota Transplant Decreases Mortality in Patients With Refractory Severe and Severe-Complicated Clostridium difficile Infection, Including Cases Not Eligible for Colectomy

Wednesday, October 18
8:50 AM - 9:00 AM
Location: Valencia Ballroom D (Level 4)



Award: 2017 Fellows-in-Training Award (Colon Category)

Category: Colon       

Yao-Wen Cheng, MD1, Emmalee Phelps, BS2, Nicholas Rogers, MD2, Sashidhar Sagi, MBBS2, Matthew Bohm, DO2, Mustapha El-Halabi, MD1, Jessica Allegretti, MD, MPH3, Zain Kassam, MD, MPH4, Huiping Xu, PhD5, Monika Fischer, MD, MSc2
1Indiana University School of Medicine, Indianapolis, IN; 2Indiana University Medical Center, Indianapolis, IN; 3Brigham & Women's Hospital, Boston, MA; 4OpenBiome, Somerville, MA; 5Indiana University–Purdue University Indianapolis, Indianapolis, IN
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.

Discussion: 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.

Supported by Industry Grant: No


Table 1. Patient Characteristics and Outcomes for Patients Hospitalized with Refractory Severe and/or Complicated CDI too Ill to be Considered for Colectomy.






























































































































































 



Total
(N = 32)



FMT not Received
(N = 17)



FMT Received
(N = 15)



P-Value



Patient characteristics



Age (years), mean (sd)



66.4 (14.2)



58.9 (13)



75 (10.1)



<0.001



Female



14 (46.7%)



7 (41.2%)



7 (53.8%)



0.71



Severe/complicated CDI



30 (93.8%)



17 (100%)



13 (86.7%)



0.21



Number of CDI episodes, median (IQR)



2 (1 – 2)



2 (1 - 2)



2 (1 - 5)



0.064



Charlson comorbidity score, mean (sd)



5.8 (2.5)



6.2 (2.6)



5.3 (2.4)



0.31



Maximum WBC, cells/mm3, median (IQR)



42.9 (26.9 – 54.3)



47.4 (31.2 - 63.9)



39 (23.8 - 50)



0.18



Minimum albumin, g/dL, mean (sd)



2.4 (0.3)



2.4 (0.4)



2.4 (0.3)



0.89



Immunosuppression



1 (3.1%)



1 (5.9%)



0 (0%)



1



Acute kidney injury



28 (87.5%)



17 (100%)



11 (73.3%)



0.038



Fever



19 (59.4%)



12 (70.6%)



7 (46.7%)



0.28



Hypotension



27 (84.4%)



16 (94.1%)



11 (73.3%)



0.16



Megacolon



7 (21.9%)



1 (5.9%)



6 (40.0%)



0.033



Vasopressor use



16 (50.0%)



11 (64.7%)



5 (33.3%)



0.16



Mental status change



21 (65.6%)



14 (82.4%)



7 (46.7%)



0.062



Ileus



8 (25.0%)



6 (35.3%)



2 (13.3%)



0.23



Mechanical ventilation



14 (43.8%)



10 (58.8%)



4 (26.7%)



0.087



Patient Outcomes



Death during encounter or in 30 days after discharge



 



 



 



 



All-cause death



19 (59.4%)



16 (94.1%)



3 (20.0%)



<0.001



CDI-related death



17 (53.1%)



14 (82.4%)



3 (20.0%)



0.001





CDI indicates Clostridium difficile infection
 

Citation: . FECAL MICROBIOTA TRANSPLANT DECREASES MORTALITY IN PATIENTS WITH REFRACTORY SEVERE AND SEVERE-COMPLICATED CLOSTRIDIUM DIFFICILE INFECTION, INCLUDING CASES NOT ELIGIBLE FOR COLECTOMY. Program No. 65. World Congress of Gastroenterology at ACG2017 Meeting Abstracts. Orlando, FL: American College of Gastroenterology.

Yao-Wen Cheng

Indiana University School of Medicine
Indianapolis, Indiana

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65 - Fecal Microbiota Transplant Decreases Mortality in Patients With Refractory Severe and Severe-Complicated Clostridium difficile Infection, Including Cases Not Eligible for Colectomy



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