In this episode, I’ll discuss an article about fecal microbiota transplantation for the first or second Clostridioides difficile infection.
Gut microbiota restoration with fecal microbiota transplantation (FMT) is a recommended treatment option for patients with multiple recurring episodes of C difficile. Evidence surrounding the optimal timing of this treatment continues to evolve, and retrospective data has suggested that early implementation of FMT may improve outcomes.
Recently, a group of authors published the first randomized, double-blind, placebo-controlled trial of FMT or placebo after 10 days of vancomycin treatment for the first or second episode of C diff infection (CDI).
42 patients were randomly assigned in a 1:1 ratio to fecal microbiota transplantation or placebo administered on day 1 and again between day 3 and 7, after they all had received 125 mg oral vancomycin four times daily for 10 days.
The primary endpoint was the resolution of C difficile-associated diarrhea 8 weeks after treatment.
The trial was stopped after half of the planned enrollment was complete for ethical reasons because a significantly lower rate of resolution was identified in the placebo group compared with the fecal microbiota transplantation group.
19 of 21 patients in the faecal microbiota transplantation group and seven of 21 patients in the placebo group had resolution of C difficile-associated diarrhea at week 8, a statistically significant difference. The absolute risk reduction in favor of Early FMT was 57%. There were no differences in safety-related outcomes between groups and there were no deaths or colectomies during the 8-week follow-up period in either group.
The authors concluded:
In patients with first or second C difficile infection, first-line faecal microbiota transplantation is highly effective and superior to the standard of care vancomycin alone in achieving sustained resolution from C difficile.
Despite the limitations of a small study and that studies terminated early tend to overestimate treatment effects, this was a randomized placebo controlled trial of FMT and is likely to convince many clinicians that early FMT is a legitimate and perhaps superior treatment option as soon as the first episode of C diff infection.
Fecal microbiota transplantation is an evolving therapy with several pharmacotherapy considerations regarding antibiotic use before and after FMT, when to use pro GI-motility vs anti GI-motility agents, and whether acid suppression is necessary. Members of the Hospital Pharmacy Academy have access to practical training on these FMT issues from a pharmacist’s point of view. From practical training on clinical topics to support from myself and other members in the forums, the Hospital Pharmacy Academy has all you need to take your skills to the next level in one place. To get instant access go to pharmacyjoe.com/academy.
If you like this post, check out my book – A Pharmacist’s Guide to Inpatient Medical Emergencies: How to respond to code blue, rapid response calls, and other medical emergencies.