PATIENT OUTCOMES OF INTESTINAL MICROBIOTA TRANSPLANTATION FOR SEVERE AND FULMINANT CLOSTRIDIOIDES DIFFICILE INFECTION: RESULTS FROM A NATIONAL REGISTRY.

Introduction: Intestinal microbiota transplantation (IMT) is an effective therapy for recurrent Clostridioides difficile infection (rCDI) and a promising therapy for severe/fulminant CDI non-responsive to antibiotics. Here we present a cohort of patients who received IMT for severe/fulminant CDI from a national IMT registry.
Methods: Participants who received IMT material from OpenBiome are requested to participate in a national de-identified registry maintained by the University of Minnesota. The registry began in September 2022. Data on inpatient IMT procedures was collected through November 17, 2023. Providers receive a survey with each unit of IMT. Continued access to OpenBiome IMT material is contingent upon participation in the registry. At 30 days post IMT, a follow-up survey is sent to the provider to obtain information on CDI outcomes and complications. For this study, the registry was queried to identify all individuals who received IMT in the hospital with an indication for severe or fulminant CDI (defined by the treating provider).
Results: Seventy-eight patients from 41 sites were classified as severe-fulminant (demographics in Table 1). At the time of IMT, 32% of patients received concomitant anti-CDI antibiotics. IMT was performed by either colonoscopy or flexible sigmoidoscopy in 97% (76/78) of cases (2 unspecified). The 30-day follow-up survey was completed for 52 patients (66.7% response rate). The overall provider reported success rate was 67% (Table 2). Non-white race was significantly associated with IMT failure (p=0.01). Co-administration of antibiotics at the time of IMT for CDI did not affect the success rate (68% with antibiotics v 67% without antibiotics). The rCDI rate at 30-days post IMT for severe/fulminant CDI was 31.4% (16/51, 1 missing, Table 2). Non-white race (p=0.009), and subsequent non-CDI infection (p=0.007) were significantly associated with rCDI. Non-CDI infections included two urinary tract infection, one skin infection, and one respiratory tract infection. Infections resolved with antibiotics, but all four patients developed rCDI. Seven serious adverse events were reported from four patients including bacteremia (1), bowel perforation (1), disease progression (3) and septic shock (2). The bacteremia was Klebsiella aerogenes in a 71-year-old patient in the ICU with invasive catheters, total parenteral nutrition, intubated and pressor support. None were considered related to IMT among this high-risk group.
Conclusions: Patients with severe/fulminant CDI represent a high-risk group that can benefit from timely IMT. Non-white patients may be at particularly higher risk of failing IMT for severe/fulminant CDI and subsequent rCDI. Co-administration of antibiotics does not appear to affect CDI outcomes. More research is needed to determine the optimal IMT treatment strategy and post IMT management to mitigate CDI.