Update on microbiota-derived therapies for recurrent Clostridioides difficile infections.
Level 5 - mechanism / opinion, no new human data
Narrative review synthesizing published phase II/III trials and historical FMT data without systematic review or meta-analysis protocol
PubMed 38101472 · doi:10.1016/j.cmi.2023.12.007
What was done
Reviewed available phase II and phase III clinical trial data evaluating commercially developed microbiota-derived medicinal products (RBX2660, SER-109, and VE303) compared to traditional faecal microbiota transplantation (FMT) for preventing recurrent Clostridioides difficile infection (rCDI).
What was found
All evaluated products showed efficacy versus placebo in preventing rCDI, with overall safety profiles characterized mainly by mild gastrointestinal symptoms. However, risk differences between treatment and placebo arms were lower than previously described for FMT: FMT Δ = 50.5%, RBX2660 phase III Δ = 13.1%, SER-109 phase III Δ = 28%, and high-dose VE303 phase II Δ = 31.7%. Heterogeneity in inclusion criteria, episode timing, and diagnostics limited direct cross-trial comparisons.
Why it matters
Standardized human microbiota-derived medicinal products offer regulated alternatives to FMT, though indirect comparisons suggest differences in risk reduction margins across products.
Limits
This is a narrative review lacking direct head-to-head randomized trials between the new products or against FMT. Total sample sizes across reviewed studies are not reported in the abstract.
Cited by
- contradicts No probiotic preparation has been approved as a medical drug intervention by the FDA or the European Medicines Agency.