The National Institutes of Health (NIH) is funding innovative mechanistic research to accelerate the development of effective precision probiotic interventions. The initiative aims to address the heterogeneity in humans that often leads to inconsistent therapeutic responses to probiotics.
The funding opportunity (NOFO) supports research to identify, understand, and develop strategies to overcome barriers in precision probiotic interventions. The focus is on characterizing person-specific features affecting probiotic responses to identify subgroups of probiotic responders, which may then enhance clinical outcomes.
Two-Phased Approach
The research will follow a milestone-driven, biphasic award mechanism. The first phase, funded by the R61 mechanism, will provide 1-2 years of support to identify host biological patterns correlated with differences in probiotic clinical effects. These patterns may include the native microbiome, immune system, sex and/or gender, diet, age, genetic background, lifestyle, or health history. Studies in this phase will utilize observational or secondary data analysis.
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. This will be achieved through rigorous mechanistic study designs in animal models or human subjects. The combined R61/R33 funding should not exceed 5 years.
Transition and Approval
Transition to the R33 phase requires administrative review by NIH staff and is not guaranteed. Approval 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.
Scope and Limitations
This NOFO will not support efficacy or effectiveness clinical trials. The focus is on mechanistic research to understand and address the underlying factors influencing probiotic responses.
