Update on microbiota-derived therapies for recurrent Clostridioides difficile infections.

Area of Science:

• Microbiome Therapeutics
• Infectious Diseases
• Gastroenterology

Background:

• Faecal microbiota transplantation (FMT) is the standard for recurrent Clostridioides difficile infection (rCDI).
• Commercially developed microbiota-derived products are emerging as alternatives, with distinct compositions and administration routes.
• FDA-approved products include Rebyota (RBX2660) and VOWST (SER-109), with VE303 in Phase III trials.

Purpose of the Study:

• To review and compare microbiota-derived treatments in advanced clinical evaluation for rCDI against FMT.
• To analyze available data on efficacy, safety, and product characteristics of emerging rCDI therapies.

Main Methods:

• Review of Phase II and III clinical trials evaluating microbiota-derived medicinal products for rCDI prevention.
• Comparison of efficacy and safety data against placebo and historical FMT data.
• Analysis of product composition (stool-derived vs. defined consortia) and administration routes.

Main Results:

• RBX2660, SER-109, and VE303 demonstrated efficacy in preventing rCDI in high-risk patients compared to placebo.
• Observed differences in recurrence risk reduction were lower than previously reported for FMT.
• All evaluated treatments exhibited a favorable safety profile, with primarily mild gastrointestinal side effects.

Conclusions:

• Stool-derived products and bacterial consortia require clear differentiation in characterization and risk assessment.
• Long-term post-marketing evaluation is crucial, similar to FMT registries.
• Further research is needed to determine optimal patient populations and administration routes for these novel rCDI therapies.