Background
Study overview
- A multicenter, phase II, double-blind, randomized, placebo-controlled trial
- Participants had recurrent CDI diagnosed by PCR or toxin enzyme immunoassay.
- Participants were randomized 1:1 to receive CP101 or placebo after antibiotics (1)
Primary outcome measures
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication, Safety
Results
- 198 participants were analyzed: 102 received CP101, 96 received placebo.
- 74.5% of CP101 group had no recurrence through week 8 vs 61.5% of placebo group (P = .0488).
- Efficacy was durable through week 24: 73.5% for CP101 vs 59.4% for placebo (P = .0347).
- Efficacy was consistent regardless of diagnostic method or recurrence number.
- CP101 group showed rapid, durable microbiome diversity increase.
- Adverse events were similar between groups (1)
Conclusion
- CP101 reduced recurrent CDI more effectively than placebo.
- Safety profile of CP101 was similar to placebo (1)
References
(1) Allegretti et al. 2025 Gastroenterology 168(2): 357-366
