PUNCH CD3 (secondary analysis)
Trial question
What is the role of fecal microbiota, live-jslm (REBYOTA) in patients with recurrent C. difficile infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
69.0% female
31.0% male
N = 185
185 patients (128 female, 57 male).
Inclusion criteria: adult patients with recurrent C. difficile infection.
Key exclusion criteria: previous fecal transplant; history of IBD; diagnosis of IBS; compromised immune system; absolute neutrophil count < 1,000 cells/mcL during screening; pregnancy, lactation, or intends to become pregnant.
Interventions
N=128 live-jslm (1 dose and followed up for 8 weeks).
N=57 placebo (normal saline solution and followed up for 8 weeks).
Primary outcome
Improvement in total Clostridioides difficile Health-Related Quality-of-Life Survey score at week 8
75.8%
69.2%
75.8 %
56.8 %
37.9 %
18.9 %
0.0 %
Live-jslm
Placebo
Significant
increase ▲
NNT = 15
Significantly greater improvement in total C. difficile Health-Related Quality-of-Life Survey score at week 8 (75.8% vs. 69.2%; AD 7.2%, 95% CI 1.2 to 13.2).
Secondary outcomes
Significantly greater improvement in physical C. difficile Health-Related Quality-of-Life Survey score at week 8 (84.4% vs. 78%; AD 6.6%, 95% CI 0.8 to 12.3).
Significantly greater improvement in mental C. difficile Health-Related Quality-of-Life Survey score at week 8 (66.3% vs. 59.4%; AD 8.3%, 95% CI 1.4 to 15.3).
No significant difference in improvement in social C. difficile Health-Related Quality-of-Life Survey score at week 8 (80.1% vs. 73%; AD 6.5%, 95% CI -0.6 to 13.6).
Conclusion
In adult patients with recurrent C. difficile infection, live-jslm was superior to placebo with respect to improvement in total C. difficile Health-Related Quality-of-Life Survey score at week 8.
Reference
Kevin W Garey, Erik R Dubberke, Amy Guo et al. Effect of Fecal Microbiota, Live-Jslm (REBYOTA [RBL]) on Health-Related Quality of Life in Patients With Recurrent Clostridioides difficile Infection: Results From the PUNCH CD3 Clinical Trial. Open Forum Infect Dis. 2023 Jul 20;10(8):ofad383.
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