Early results of fecal microbial transplantation protocol implementation at a community-based university hospital

Abstract

Introduction:Clostridium difficile (CD) is a serious and increasingly prevalent healthcare-associated infection. The pathogenesis of CD infection (CDI) involves the acquisition of CD with a concurrent disruption of the native gut flora. Antibiotics are a major risk although other contributing factors have also been identified. Clinical management combines discontinuation of the offending antibiotic, initiation of CD-specific antibiotic therapy, probiotic agent use, fecal microbiota 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 (FMTP) at our community-based university hospital.Methods:After obtaining Institutional Review Board and Infection Control Committee approvals, we implemented an institution-wide FMTP for patients diagnosed with CDI. Prospective tracking of all patients receiving FMT between July 1, 2015, and February 1, 2017, was conducted using REDCap™ electronic data capture system. According to the FMTP, indications for FMT included (a) three or more CDI recurrences, (b) two or more hospital admissions with severe CDI, or (c) first episode of complicated CDI (CCDI). Risk factors for initial infection and for treatment failure were assessed. Patients were followed for at least 3 months to monitor for cure/failure, relapse, and side effects. Frozen 250 mL FMT samples were acquired from OpenBiome (Somerville, MA, USA). After 4 h of thawing, the liquid suspension was applied using colonoscopy, beginning with terminal ileum and proceeding distally toward mid-transverse colon. Monitored clinical parameters included disease severity (Hines VA CDI Severity Score or HVCSS), concomitant medications, number of FMT treatments, non-FMT therapies, cure rates, and mortality. Descriptive statistics were utilized to outline the study results.Results:A total of 35 patients (mean age 58.5 years, 69% female) were analyzed, with FMT-attributable primary cure achieved in 30/35 (86%) cases. Within this subgroup, 2/30 (6.7%) patients recurred and were subsequently cured with long-term oral vancomycin. Among five primary FMT failures (14% total sample), 3 (60%) achieved medical cure with long-term oral vancomycin therapy and 2 (40%) required colectomy. For the seven patients who either failed FMT or recurred, long-term vancomycin therapy was curative in all but two cases. For patients with severe CDI (HVCSS ≥3), primary and overall cure rates were 6/10 (60%) and 8/10 (80%), respectively. Patients with CCDI (n = 4) had higher HVCSS (4 vs. 3) and a mortality of 25%. Characteristics of patients who failed initial FMT included older age (70 vs. 57 years), female sex (80% vs. 67%), severe CDI (80% vs. 13%), and active opioid use during the initial infection (60% vs. 37%) and at the time of FMT (60% vs. 27%). The most commonly reported side effect of FMT was loose stools.Conclusions:This pilot study supports the efficacy and safety of FMT administration for CDI in the setting of a community-based university ho...

Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection in Patients With Multiple Comorbidities: Long-Term Safety and Efficacy Results From a Tertiary Care Community Hospital

“…Primary success rate in our institution was 90% (18/20) ( Fig. 1 ) and overall success rate was 100% over a long-term median follow-up period of 25.4 months which is comparable to the rates reported in other studies [ 16 , 18 , 44 , 45 ].…”

Faecal microbiota transplantation for recurrent Clostridioides difficile infection: An updated systematic review and meta-analysis

“…While most studies reported clinical outcomes according to the CDAD definition and had a similar long-term follow-up, the short-term evaluation of the FMT effect varied. In some studies [45] , the treatment effect was evaluated on day 4 while other [ 44 , 58 ] waited until week 1 after FMT despite ongoing CDAD symptoms. The differences illustrate the difficulties in keeping a balance between overtreatment and preventing disease progression.…”

The microgenderome revealed: sex differences in bidirectional interactions between the microbiota, hormones, immunity and disease susceptibility

“…To our knowledge, no one has suggested that the sex of the donor should be considered when screening for suitability as an FMT donor, but the studies in this paper indicate that this could be an important consideration. Indeed, a recent human study found that female sex was associated with failure of FMT to cure C. difficile infection [98]. Advances in methods of cultivation, measurement and preparation of gastrointestinal bacteria are now progressing research from FMT to the development of rationally selected mixtures of bacteria with proven therapeutic efficacy, termed bacteriotherapies.…”