A randomised non-inferiority study showed that faecal microbiota transplantation was safe and not inferior to the antibiotic vancomycin in patients with primary Clostridioides difficile infection.
“C. difficile infections usually occur after antibiotic treatment, due to a disruption of the gut microbiota,” explained Dr Frederik Juul (University of Oslo, Norway). The standard treatment is antibiotics; however, the cure rate is suboptimal (71–79%) and recurrences occur frequently1.
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 patients with a primary C. difficile infection. The 100 participants were randomised 1:1 to FMT or vancomycin (125 mg, 4 times a day for 10 days). The primary endpoint was a combination of clinical cure by day 14, no recurrence by day 60, and no additional treatment needed.
A sustained clinical cure was achieved by 67% of the participants in the FMT arm and 61% of the participants in the antibiotics arm.
Adverse events (AEs) were noted in 45% and 35% of the participants in the FMT arm and vancomycin arm, respectively. “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 experimental and control arm, respectively.
“FMT is safe and non-inferior to vancomycin in patients with primary C. difficile infection,” concluded Dr Juul.