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Enhancing Mechanistic Research on Precision Probiotic Therapies (R61/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 using a milestone-driven, biphasic award mechanism. It aims to identify, understand, and develop strategies to address barriers in precision probiotic interventions to account for the heterogenicity in humans that often causes inconsistent probiotic therapeutic responses. Specifically, this NOFO solicits applications that will characterize person-specific features affecting probiotic responses to identify subgroups of probiotic responders, which may then help enhance probiotic clinical outcomes.

The first phase, funded by the R61 mechanism, will provide 1 or 2 years of support to identify 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 differences in probiotic clinical effects using observational or secondary data analysis studies. The second phase, funded under the R33 mechanism, will support studies to assess the causality of the factors identified in the R61 phase that impact probiotic responsiveness through rigorous mechanistic study designs in animal models or human subjects. This NOFO will not support efficacy or effectiveness clinical trials.

The combined R61/R33 should not exceed 5 years. Transition to the R33 phase requires administrative review by NIH staff and is not guaranteed. Approval of the transition to the R33 phase will be based on the original R61/R33 peer review recommendations, successful completion of transition milestones, any proposed changes to the R33 research based on R61 findings, program priorities, and availability of funds. It is not expected that all applications will continue to the R33 phase.

Support for a single phased award that does not need the R61 Exploratory phase is available in the companion (R33) NOFO, PAR-24-239 .

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 24-238 Expiration Date June 03, 2027