Enhancing Mechanistic Research on Precision Probiotic Therapies (R61/R33 Clinical Trial Optional)
Accelerating precision probiotic interventions by identifying subgroups of responders through unique biological patterns, aiming to enhance clinical outcomes.
Funder: National Institutes of Health
Due Dates: June 2, 2025 (New, Renewal, Resubmission, Revision) | February 2, 2026 | October 1, 2026 | June 2, 2027
Funding Amounts: Up to $350,000 direct costs/year for each phase; max 5 years total (R61: 1–2 years, R33: remainder); modular or detailed budget allowed.
Summary: Supports milestone-driven mechanistic research to identify person-specific features affecting probiotic responses, aiming to accelerate precision probiotic interventions and improve clinical outcomes.
Key Information: Applications must include clear milestones and R61-to-R33 transition criteria; efficacy/effectiveness trials are not supported; companion R33-only NOFO available for projects not needing the R61 phase.
Description
This NIH opportunity supports highly innovative, milestone-driven mechanistic research to accelerate the development of precision probiotic therapies. The program uses a biphasic R61/R33 award structure:
- R61 Phase (1–2 years): Identify unique host biological patterns (e.g., microbiome, immune system, sex, diet, age, genetics, lifestyle, health history) correlated with heterogeneity in probiotic clinical effects, using observational or secondary data analysis.
- R33 Phase (up to 3–4 years): Test the causality and mechanistic impact of these patterns on probiotic responsiveness in rigorously designed studies using animal models or human subjects.
The ultimate goal is to identify, understand, and develop strategies to address barriers in precision probiotic therapies, accounting for human heterogeneity that leads to inconsistent responses.
Note: This NOFO does not support efficacy or effectiveness clinical trials. Only mechanistic trials (studying how an intervention works, not if it works) are in scope.
