Fecal transplant noninferior to vancomycin for first C. diff infection, trial finds
The Clostridioides difficile cure rate was statistically noninferior and numerically higher in patients randomized to fecal microbiota transplantation instead of vancomycin for an initial C. difficile infection, a small open-label trial in Norway found.
For patients with an initial Clostridioides difficile infection, fecal microbiota transplantation (FMT) had similar outcomes as vancomycin, suggesting it may be considered for first-line therapy, according to the authors of a recent trial.
The open-label noninferiority trial was conducted at hospitals and primary care facilities in Norway. It included 100 adults with C. difficile who were randomized to FMT without antibiotic pretreatment or oral vancomycin, 125 mg four times daily, for 10 days. Results were published by Annals of Internal Medicine on June 17.
FMT was noninferior to vancomycin on the study's combined primary end point of clinical cure at day 14 (firm stools or less than three bowel movements daily) and no disease recurrence within 60 days. FMT met the predefined noninferiority threshold of a 25 percentage-point lower cure rate than vancomycin. Limitations of the study include its open-label design and no comparison of the interventions with fidaxomicin.
A more detailed summary of the study is available in the June 18 ACP Hospitalist, a publication exclusive to ACP members. Single sign-on is required.