MATCH (Clostridioides difficile infection)
Trial question
What is the role of fecal microbiota transplantation in patients with recurrent C. difficile infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
14.0% female
86.0% male
N = 153
153 patients (21 female, 132 male).
Inclusion criteria: patients with recurrent C. difficile infection who responded to antibiotic treatment.
Key exclusion criteria: unlikely to swallow capsules; pregnancy; receipt of cytotoxic chemotherapy or IV or SC immune globulin; confirmed neutropenia within the past 3 months; IBD or other chronic diarrheal disease; life expectancy < 8 weeks; anaphylactic food allergy; prior fecal microbiota transplantation.
Interventions
N=76 fecal microbiota transplant (oral capsule containing freeze-dried microbes with trehalose as a cryoprotectant).
N=77 placebo (matching placebo oral capsules containing trehalose and carboxymethylcellulose).
Primary outcome
Rate of recurrent Clostridioides difficile infection or death within 56 days
32.9%
29.9%
32.9 %
24.7 %
16.4 %
8.2 %
0.0 %
Fecal microbiota
transplant
Placebo
No significant
difference ↔
No significant difference in the rate of recurrent C. difficile infection or death within 56 days (32.9% vs. 29.9%; AD 3%, 95% CI -11.7 to 17.7).
Secondary outcomes
No significant difference in possible C. difficile infection at day 56 (31.6% vs. 28.6%; AD 3%, 95% CI -11.5 to 17.5).
No significant difference in definite C. difficile infection at day 56 (7.9% vs. 9.1%; ARD -1.2, 95% CI -10 to 7.6).
No significant difference in death at day 56 (1.3% vs. 1.3%).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with recurrent C. difficile infection who responded to antibiotic treatment, fecal microbiota transplant was not superior to placebo with respect to the rate of recurrent C. difficile infection or death within 56 days.
Reference
Dimitri M Drekonja, Aasma Shaukat, Yuan Huang et al. A randomized controlled trial of efficacy and safety of Fecal Microbiota Transplant for preventing recurrent Clostridioides difficile infection. Clin Infect Dis. 2024 Sep 13:ciae467.Online ahead of print.
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