FDA-approved products for recurrent C. difficile infection are termed fecal microbiota products, not live biotherapeutic products (LBPs).
Fecal microbiota products have variable strain compositions and differ from defined LBPs as per FDA guidance.
Aligning academic and industry terminology with FDA definitions may advance microbiome therapeutic development.
Guideline-Based Recommendations
Diagnosis
Identify recurrent Clostridioides difficile infection as indication for fecal microbiota product therapy.
Management
Use FDA-approved fecal microbiota products for prevention of recurrent C. difficile infection.
Monitoring & Follow-up
Monitor patient response to fecal microbiota products as per clinical standards for recurrent C. difficile infection.
Risks
Consider variability in strain composition of fecal microbiota products when assessing safety and efficacy.
Patient & Prescribing Data
Patients with recurrent Clostridioides difficile infection
FDA-approved fecal microbiota products are used despite variable strain composition; terminology differences exist between FDA and academic literature.
Clinical Best Practices
Use FDA terminology 'fecal microbiota products' when referring to approved therapies for recurrent C. difficile infection.
Recognize that fecal microbiota products differ from defined LBPs in composition and regulatory characterization.
Promote consistent terminology across academic, industry, and regulatory communications to support therapeutic development.
A retrospective cohort study of more than 520,000 hospitalized patients found no clinically meaningful improvement in deterioration or mortality with early treatment targeting community-acquired pneumonia.
