Is faecal microbiota transplantation a viable option to treat primary C. difficile infections?

Faecal microbiota transplantation (FMT) was safe and non-inferior to the antibiotic vancomycin in participants with a primary Clostridioides difficile infection, as demonstrated by a randomised non-inferiority study.

“C. difficile infections usually occur after antibiotic treatment due to a disruption of the gut microbiota,” explained Dr Frederik Juul (Oslo University Hospital, Norway) [1]. While antibiotics are the standard treatment, they achieve suboptimal cure rates (71–79%), and recurrences occur frequently. To investigate the value of FMT, Dr Juul and his research team conducted a non-inferiority trial to compare FMT with the antibiotic vancomycin among participants with a primary C. difficile infection [2]. Participants (n=100) were randomised 1:1 to receive either FMT or vancomycin (125 mg, 4 times daily for 10 days). The primary endpoint was a combination of clinical cure by day 14, absence of recurrence by day 60, and no additional treatment needed. The secondary endpoint was the percentage of patients who experienced an adverse event (AE).

A sustained clinical cure was achieved by 67% of the participants in the FMT arm and 61% of those in the antibiotics arm. AEs were noted in 45% and 35% of the participants in the FMT and vancomycin arms, respectively. All AEs were included, regardless of whether they were treatment-related.“The population had a median age of approximately 70 years,” said Dr Juul. “This advanced age is associated with a higher rate of comorbidities, explaining the relatively high AE rates in both arms.” Severe AEs were reported in 26% and 16% of the participants in the FMT and control arms, respectively. There were 2 deaths in the FMT group and 3 in the vancomycin group.

“FMT is safe and non-inferior to vancomycin in patients with primary C. difficile infection,” concluded Dr Juul.

1. 
   
   1. Nelson RL, et al. Cochrane Database Syst Rev. 2017;3(3):CD004610.
   2. Juul FE, et al. Fecal microbiota transplant versus vancomycin for primary clostridiodes difficile infection: a randomized non-inferiority trial. LB02, UEG Week 2024, 12–15 October, Vienna, Austria.

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Posted on 28 November 2024