Microbiome and Aging: Impact on Health and Disease (R01 Clinical Trial Not Allowed) | RFA AG 20 030

Opportunity Information: Apply for RFA AG 20 030

The National Institutes of Health (NIH) funding opportunity titled "Microbiome and Aging: Impact on Health and Disease (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-AG-20-030; CFDA 93.866) supports research projects that examine how the microbiome changes across the aging process and how those changes may contribute to health outcomes in older adults. The focus is on understanding both the composition of microbial communities (which organisms are present) and their functional characteristics (what they are doing biologically), with an emphasis on identifying the drivers of microbiome shifts during aging and clarifying how those shifts intersect with the development and progression of age-related chronic diseases.

A central goal of the FOA is to move beyond simple descriptions of age-related microbiome differences and into more explanatory, mechanism-oriented science. Projects are encouraged to define factors that shape the aging microbiome, which can include host biology, immune and metabolic changes, medications, diet, environment, and other exposures that accumulate or change with age. The FOA also seeks studies that connect microbiome alterations to the causes and pathophysiology of chronic conditions common in later life, meaning applicants should aim to explain plausible biological pathways through which microbiome features influence disease onset, severity, or progression rather than treating the microbiome as a stand-alone observational finding.

In addition to mechanistic understanding, the FOA explicitly invites research aimed at developing and testing targeted microbiome-relevant interventions. These interventions can include dietary approaches, drug-based strategies, or the use of live organisms (for example, probiotics or other microbial therapeutics), as long as the work fits within the non-clinical-trial boundaries of the announcement. The intent is to support research that can identify actionable levers for shifting microbiome function or composition in ways that may promote healthier aging or reduce disease risk, while still remaining within the allowable study designs under "Clinical Trial Not Allowed."

In terms of study types, the FOA permits basic mechanistic research and preclinical studies in animal models, which can be used to test causality, dissect pathways, and evaluate interventions under controlled conditions. It also allows human research that leverages existing human longitudinal cohorts, emphasizing the value of repeated measures over time to understand how microbiome features evolve with aging and how those trajectories relate to later health outcomes. The emphasis on existing cohorts signals that the FOA is designed to capitalize on established longitudinal resources rather than launching new clinical trials or large new prospective enrollment efforts under this mechanism.

The award mechanism is an R01 research project grant under the NIH discretionary grant category in health. The original closing date listed for the opportunity was October 30, 2019, and the posting date (creation date) was July 23, 2019. Specific values for an award ceiling and expected number of awards are not provided in the source data shown.

Eligibility is broad and includes many common domestic applicant categories such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as specified); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA also highlights additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal government agencies, and U.S. territories or possessions.

At the same time, the FOA places strict limits on foreign involvement. Non-domestic (non-U.S.) institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined in the NIH Grants Policy Statement are not allowed. In practical terms, applicants need to ensure the applicant organization is U.S.-based and that the proposed work does not include foreign components that would violate these restrictions.

Overall, this FOA is designed for research teams aiming to clarify how aging reshapes the microbiome, why those changes happen, how they relate to the biology of chronic diseases of aging, and how targeted non-clinical-trial interventions might modify microbiome-related mechanisms to improve health in older populations.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Microbiome and Aging: Impact on Health and Disease (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
• This funding opportunity was created on 2019-07-23.
• Applicants must submit their applications by 2019-10-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA AG 20 030

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