Enhancing Mechanistic Research on Precision Probiotic Therapies (R61/R33 Clinical Trial Optional)
Open Posted
- Opportunity number
- PAR-25-211
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Categories
-
- Education
- Health
- Eligible applicants
-
- Higher Education Inst. (Public)
- Tribal Organizations (Not Federally Recognized)
- Special District Governments
- Public or Indian Housing Auth.
- County Governments
- Other
- 501(c)(3) Nonprofits
- For Profit Organizations
- City/Township Governments
- Tribal Governments (Federally Recognized)
- State Governments
- Higher Education Inst. (Private)
- Independent School Districts
- Non-501(c)(3) Nonprofits
- Small Businesses
- Points of contact
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- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health seeks applicants for "Enhancing Mechanistic Research on Precision Probiotic Therapies (R61/R33 Clinical Trial Optional)," a phased innovation award supporting mechanistic research on precision probiotic interventions with an application due date of June 2, 2027. The R61/R33 mechanism is designed to characterize person-specific features affecting probiotic responses, identify subgroups of responders, and develop strategies to address heterogeneity in human probiotic responsiveness. The combined R61/R33 award should not exceed 5 years.
Applicant eligibility is broad: higher education institutions (public and private), tribal organizations (both federally and non-federally recognized), state and local governments, 501(c)(3) and non-501(c)(3) nonprofits, for-profit organizations, public or Indian housing authorities, and independent school districts are eligible. Additionally eligible are Alaska Native and Native Hawaiian serving institutions, Hispanic-serving institutions, HBCUs, Asian American Native American Pacific Islander serving institutions (AANAPISIs), tribally controlled colleges and universities, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Non-domestic entities and foreign components, as defined in the NIH Grants Policy Statement, are not eligible; non-domestic components of U.S. organizations may not apply.
The R61 exploratory phase funds up to 2 years of observational or secondary data analysis studies to identify unique host biological patterns (native microbiome, immune system, gender, diet, age, genetic background, lifestyle, health history) correlated with heterogeneous probiotic clinical effects. The R33 phase supports mechanistic studies in animal models or human subjects to assess whether identified patterns predict improved probiotic responsiveness. Transition from R61 to R33 is administratively reviewed and contingent on achievement of transition milestones specified in the R61 application. A companion R33-only NOFO (PAR-AT-24-XXX, TEMP-25413) is available for applicants who do not require the R61 exploratory phase.
The opportunity is assigned to multiple NIH program listings: Office of Research on Women's Health (CFDA 93.313), Cancer Cause and Prevention Research (CFDA 93.393), Oral Diseases and Disorders Research (CFDA 93.121), Research and Training in Complementary and Integrative Health (CFDA 93.213), and Aging Research (CFDA 93.866).
Synopsis
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).
Eligibility
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-211-Full-Announcement.html | HTML file | |
| PKG00288343.pdf |
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