Journal Club

Fecal Transplantation for the Treatment of First or Second Clostridioides difficile Infection

By Zeina A. Kanafani, MD, MS, FIDSA

Clostridioides difficile infection (CDI) remains the most common cause of antibiotic-associated diarrhea and a major cause of morbidity, especially in high-risk patients such as elderly individuals with multiple comorbid conditions who are exposed to antibiotics. Fecal microbiota transplantation (FMT) following antibiotic use has been recommended for patients with multiple recurrences. FMT has been shown to be an effective therapeutic option for patients who have experienced three or more recurrences. However, no large trials of FMT for first or second CDIs have been performed. 

In a recent study published in The Lancet Gastroenterology & Hepatology, investigators from Denmark conducted a double-blinded controlled clinical trial where patients with first- and second-time CDIs were randomized to receive FMT or placebo on day 1 and between days 3 and 7. All patients had received 10 days of oral vancomycin prior to randomization. The primary outcome for resolution of diarrhea was assessed at 8 weeks after treatment.

A total of 42 patients were randomized (21 to FMT and 21 to placebo). The infection was considered severe in 32 patients (76%), with 22 patients (52%) requiring hospital admission. There were 25 first episodes and 17 second episodes of CDI. The trial was terminated prematurely after interim analysis showed a significantly lower rate of CDI resolution in the placebo group. In the intervention group, 19 patients (90%) achieved the primary outcome (resolution of infection at 8 weeks) compared to seven patients (33%) in the placebo group (P = .0003), with an absolute risk reduction for recurrence of 57%. Rescue FMT was administered for 13 patients in the placebo group. The secondary outcome of resolution of infection at week 1 was not significantly different between the two groups. Serious adverse events possibly related to treatment were reported in one patient in the FMT group and in two patients in the placebo group, with no deaths or colectomies recorded in either group.

Consequently, for patients with a first or second CDI, oral vancomycin followed by FMT is superior to vancomycin alone, according to this study.

(Baunwall et al. Lancet Gastroenterol Hepatol. 2022;7(12):1083-1091.)