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Enhancing Mechanistic Research on Precision Probiotic Therapies (R33 Clinical Trial Optional)

National Institutes of Health

The purpose of this notice of funding opportunity (NOFO) is to support highly innovative mechanistic research to accelerate the development of effective precision probiotic interventions. The NOFO aims to identify, understand, and develop strategies to address barriers in precision probiotic interventions' development to account for human heterogenicity resulting in inconsistent responses to probiotic treatments. Specifically, this NOFO solicits R33 applications that will assess the causality of person-specific features or patterns affecting probiotic responses and identify subgroups of probiotic responders in order to enhance therapeutic outcomes.

This NOFO will support studies that assess whether host biological patterns (e.g., native microbiome, immune system, sex and/or gender, diet, age, genetic background, lifestyle, or health history) that are correlated with clinical probiotic effects can modulate responsiveness to probiotic interventions. Well-suited applications must offer rigorously designed mechanistic studies using relevant/innovative animal models or human subjects. This NOFO is intended to support projects where potential host biological patterns that are correlated with probiotic usage or interventions have been identified, as demonstrated with supportive preliminary data, which require further mechanistic studies to test for causality. This NOFO will not support efficacy or effectiveness clinical trials.

Applicants pursuing early-stage research to identify host biological patterns that may affect probiotic health outcomes should consider the companion (R61/R33) PAR-24-238 .

This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).

Application Deadlines: Oct. 1, 2024; June 2, 2025; Feb 2, 2026; Oct 1, 2026; June 2, 2027

PAR 24-239 Expiration Date June 03, 2027