Advancing Mechanistic Probiotic/Prebiotic and Human Microbiome Research (R01 Clinical Trial Not Allowed) | PA 18 876

Opportunity Information: Apply for PA 18 876

The National Institutes of Health (NIH) funding opportunity titled "Advancing Mechanistic Probiotic/Prebiotic and Human Microbiome Research (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number: PA-18-876) supports research that digs into how probiotics, prebiotics, and combined prebiotic/probiotic strategies actually work at a biological and mechanistic level. The emphasis is on foundational science that can move the field beyond general associations and toward clear cause-and-effect understanding relevant to human health and disease. A key point is that this is an R01 grant mechanism and clinical trials are not allowed under this announcement, so projects need to be positioned as basic or mechanistic research rather than interventional human trials designed to test clinical outcomes.

The opportunity has two central goals. First, it aims to stimulate basic and mechanistic studies that help enable the development of effective probiotic strains or prebiotic/probiotic combinations. This includes research that clarifies why certain strains or ingredients work, under what conditions they work, and what biological pathways they influence. Second, it seeks to define measurable biological outcomes that can be used to evaluate efficacy in appropriate experimental systems, particularly in test systems and animal models. In practice, that means identifying robust biomarkers, functional readouts, immune or metabolic changes, microbial community shifts, or other mechanistic endpoints that can later support translational work, even if this FOA itself is not funding clinical trials.

NIH is explicitly encouraging a wide range of model systems and approaches, including in vitro (lab-based), in vivo (animal), ex vivo (tissues or samples studied outside the organism), and in silico (computational) methods. The scientific focus is on probiotic/prebiotic strain selectivity, interaction, and function. That includes questions like how specific microbes respond to specific substrates, how microbial strains compete or cooperate, how they colonize or persist, how they produce metabolites, and how those metabolites or microbial signals affect host physiology. The call also fits well with studies that integrate microbiome composition data with function, such as linking genes to pathways, pathways to metabolites, and metabolites to host responses, rather than stopping at descriptive sequencing results.

Another major theme is collaboration across disciplines. The FOA highlights the value of inter- and multidisciplinary teams spanning nutritional science, immunology, microbiomics, genomics, other "omics" fields, biotechnology, and bioinformatics. This reflects how mechanistic microbiome work often requires combined expertise, for example pairing gnotobiotic or defined-community animal models with metabolomics and immune profiling, or using computational modeling to predict strain-substrate interactions and then validating them experimentally. Proposals that can connect multiple layers of biology (microbial genes, microbial products, host receptors, immune or metabolic pathways, and measurable phenotypes) are strongly aligned with the intent of the announcement.

Eligibility is broad and includes many organization types in the United States, such as state, county, and local governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; independent school districts; special district governments; public housing authorities/Indian housing authorities; and Native American tribal governments and organizations (including federally recognized tribal governments and other tribal organizations). The FOA also calls out additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISI), along with faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies.

There are important limits related to non-U.S. participation. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are not eligible to apply directly. Non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, which typically means a U.S. applicant organization may include certain well-justified project elements carried out abroad when scientifically necessary, even though the primary applicant must be domestic.

From an administrative standpoint, the opportunity is categorized as discretionary funding and uses the NIH grant funding instrument. The activity category is listed under education and health, and the associated CFDA numbers include 93.121, 93.279, 93.321, 93.393, 93.396, and 93.846. The FOA was created on July 25, 2018, and the original closing date listed in the source information is September 7, 2021. No award ceiling or expected number of awards is provided in the supplied listing, which is common in NIH announcements where budgets depend on project scope and institute priorities and where final award counts can vary by fiscal year.

Overall, this FOA is best suited for investigators proposing rigorous mechanistic studies that explain how prebiotics and probiotics produce specific biological effects, and that define objective, testable outcomes to evaluate those effects in well-controlled experimental systems. The spirit of the announcement is to strengthen the evidence base needed to design better probiotic and prebiotic strategies in the future by clarifying mechanisms, identifying meaningful functional endpoints, and promoting integrative, team-based science across microbiome and host biology.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Advancing Mechanistic Probiotic/Prebiotic and Human Microbiome Research (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): 93.121, 93.279, 93.321, 93.393, 93.396, 93.846.
• This funding opportunity was created on 2018-07-25.
• Applicants must submit their applications by 2021-09-07. (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 PA 18 876

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