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Enhancing Mechanistic Research on Precision Probiotic Therapies (R33 Clinical Trial Optional)

ID: PAR-25-210 • Type: Posted

Description

The purpose of this notice of funding opportunity (NOFO) is to support highly innovative mechanistic research to accelerate precision probiotic interventions. Specifically, this NOFO solicits R33 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. This NOFO will support studies to assess the ability of the unique patterns of host biology (e.g., native microbiome, immune system, gender, diet, age, genetic background, lifestyle, and health history) that are correlated with probiotic usage to detect the improvement of probiotic responsiveness. Well-suited applications must offer rigorously designed mechanistic studies using relevant/innovative animal models or in human subjects. This NOFO is intended to support projects where potential host biological patterns that are correlated with probiotic usage have been identified, as demonstrated with supportive preliminary data, but require further mechanistic studies to test for their causality or predictability. Applicants pursuing early-stage research to identify host biological patterns that may affect probiotic health outcomes should consider the companion (R61/R33) NOFO PAR-AT-24-XXX (TEMP-25412).
Background
The National Institutes of Health (NIH), specifically through the National Center for Complementary and Integrative Health (NCCIH), is issuing this Notice of Funding Opportunity (NOFO) to support innovative mechanistic research aimed at enhancing precision probiotic therapies.

The goal is to address barriers in developing effective probiotic interventions that account for human heterogeneity, which leads to inconsistent responses to probiotics. This initiative seeks to identify and understand person-specific biological features that influence probiotic efficacy.

Grant Details
The NOFO solicits R33 applications focused on mechanistic studies that assess the causality of individual biological patterns affecting probiotic responses. Key tasks include:
1) Determining causal effects of host biological patterns on modifying probiotic responses in relevant preclinical models or human populations;
2) Elucidating mechanisms through which these patterns modify probiotic responses;
3) Optimizing computational and AI tools to identify host biological factors.

Applications must demonstrate rigorous study designs using innovative animal models or human subjects, with preliminary data supporting identified biological patterns.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local and state governments, and tribal governments. Special encouragement is given to institutions serving underrepresented populations such as Historically Black Colleges and Universities (HBCUs) and Hispanic-serving institutions. Individuals from diverse backgrounds are also encouraged to apply.

Period of Performance
The total project period may not exceed 4 years, with a budget cap of $350,000 in direct costs per year.

Grant Value
The total value of the grant is contingent upon NIH appropriations, with individual awards potentially reaching up to $350,000 annually.

Overview

On 10/31/24 the National Institutes of Health posted grant opportunity PAR-25-210 for Enhancing Mechanistic Research on Precision Probiotic Therapies (R33 Clinical Trial Optional). The grant will be issued under grant program 93.121 Oral Diseases and Disorders Research.

Timing

Posted Date
Oct. 31, 2024, 12:00 a.m. EDT
Closing Date
June 2, 2027, 12:00 a.m. EDT Due in 907 Days
Last Updated
Oct. 31, 2024, 2:27 p.m. EDT
Version
1
Archive Date
July 8, 2027

Eligibility

Eligible Applicants
County governments
State governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
Public housing authorities/Indian housing authorities
Native American tribal governments (Federally recognized)
Public and State controlled institutions of higher education
City or township governments
Small businesses
Private institutions of higher education
For profit organizations other than small businesses
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Independent school districts
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
Additional Info
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.

Contacts

Contact
National Institutes of Health
Contact Email
Email Description
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Contact Phone
(301) 402-2541
Additional Information
https://grants.nih.gov/grants/guide/pa-files/PAR-25-210.html

Documents

Posted documents for PAR-25-210

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