Hey guys,
I need your feedback regarding the limitation of this paper by Krista et al. (2017)
Treatment of recurrent Clostridium difficile infection using fecal microbiota transplantation in patients with inflammatory bowel disease.
Below is the methodology:
Inclusion criteria:
1. Informed consent
2. Documentation of at least 2 spontaneous relapses (recurrence within 3 months of discontinuation of anti-CDI antibiotic treatment + diarrheal symptoms + absence of another antibiotics given for a non-CDI infection ) of C. difficile infection following the initial episode of infection
3. Failure of at least 1 extended antibiotics (Treatment given > 6 weeks or longer) regimen to clear the infection
4. Documentation of CDI by stool testing within 2 months of FMT
Exclusion criteria:
1. Anticipation of non-CDI antibiotics treatment within 3 months of FMT
2. Life expectancy of < 2 years if patients was able to tolerate suppressive therapy with vancomycin, 125 mg daily
Patients from our entire FMT cohort who had a diagnosis of IBD (either preceding FMT or diagnosed de novo at the time of FMT) were included in this analysis. The subtype of IBD, ulcerative colitis (UC) or Crohn’s disease, was assigned based on patient history, previous endoscopic findings, and colonoscopic findings at the time of FMT. Patients with a past diagnosis of IBD, but lacking any evidence for the diagnosis during the FMT colonoscopy were not included in this case series. Colono scopic findings at the time of FMT were used to type UC as either left-sided or pancolitis and Crohn’s dis- ease as ileal, ileocolonic, or colonic only. Severity of IBD was determined using the Mayo endoscopic score and the simplified endoscopic activity score for Crohn’s disease for UC and Crohn’s disease, respectively. Several instances of indeterminate colitis diagnosis were classified either as ulcerative colitis (UC) or Crohn’s disease based on the most prominent characteristics of each. All patients underwent a standardized clinic visit before FMT during which demographic information and disease history and characteristics were documented. Importantly, one of the eligibility criteria was a relapse of CDI following an extended course of anti biotics, either a vancomycin taper or vancomycin followed without interruption by a chaser with rifaximin or fidaxomicin. All FMT procedures were performed via colonoscopy using microbiota material from standardized, unrelated donors. Baseline levels of C-reactive protein and erythrocyte sedimentation rate were measured on the day of the procedure. Microbiota material was the frozen/thawed preparation described previously. Success of FMT was defined as conversion to a C. difficile negative status within 2 months of the procedure or complete resolution of diarrhea (< 3 formed bowel movements per day). All subjects had a post FMT clinical visit at 2 months to document response and need for escalation of underlying IBD therapy.
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