Enhancing Mechanistic Research on Precision Probiotic Therapies (R61/R33 Clinical Trial Optional)
Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.
If you can identify why some people respond to probiotics and others don't, NIH will fund two phases of research (up to $5M range, typically) to validate your predictive biomarkers.
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What this is
The NIH is funding mechanistic research on precision probiotic therapies through a phased R61/R33 award mechanism. The R61 phase (up to 2 years) focuses on identifying host biological patterns (microbiome, immunity, genetics, diet, lifestyle) that correlate with probiotic response variability using observational or secondary data analysis. The R33 phase then tests whether those patterns can predict probiotic responsiveness in rigorous mechanistic studies with animal models or human subjects. Total award duration cannot exceed 5 years, and advancement from R61 to R33 is contingent on meeting predefined transition milestones.
Who can apply
Broadly eligible: small businesses, nonprofits (with or without 501(c)(3) status), universities, for-profit companies, state/local governments, and Native American tribal organizations. No geographic restriction. No explicit size cap mentioned, but designed for research teams with mechanistic expertise in probiotics, microbiome, or host-pathogen interactions.
Eligible applicant types
- City or township governments
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- County governments
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Public and State controlled institutions of higher education
- Small businesses
- Public housing authorities/Indian housing authorities
- State governments
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized tribal governments)
- Independent school districts
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- For profit organizations other than small businesses
- Private institutions of higher education
- Special district governments
Full description — from the agency
The purpose of this notice of funding opportunity (NOFO) is to support highly innovative mechanistic research to accelerate precision probiotic interventions using a milestone-driven, biphasic award mechanism, R61/R33 Phased Innovation Award. Specifically, this NOFO solicits applications that will characterize person-specific features affecting probiotic responses to identify subgroups of probiotic responders and to enhance probiotic clinical outcomes. The ultimate goal of this NOFO is to identify, understand, and develop strategies to address barriers in precision probiotic therapies to account for the heterogenicity in humans that causes inconsistent probiotic responses. The first phase, funded by the R61, will providing for up to 2 years to identify unique host biological patterns (e.g., native microbiome, immune system, gender, diet, age, genetic background, lifestyle, and health history) that are correlated with heterogeneity of probiotic clinical effects using observational or secondary data analysis studies. The second phase, funded under the R33, will support studies to assess the ability of the unique patterns determined in the R61 phase to detect the improvement of probiotic responsiveness in rigorously designed mechanistic studies in relevant animal models or in human subjects. The combined R61/R33 should not exceed 5 years. Transition from the R61 to the R33 phase of the award will be administratively reviewed and will be determined based on successful completion of Transition Milestones that need to be clearly specified in the R61 phase application. Support for a single phased award that does not need the R61 Exploratory phase is available in the companion (R33) NOFO, PAR-AT-24-XXX (TEMP-25413).
Topics: precision probiotic therapy · mechanistic research · biomarker discovery · personalized medicine · microbiome analysis · clinical translation · phased innovation award
Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.