Advancing Translational and Clinical Probiotic/Prebiotic and Human Microbiome Research (R01 Clinical Trial Optional) | PA 18 001

Opportunity Information: Apply for PA 18 001

The National Institutes of Health (NIH) funding opportunity titled "Advancing Translational and Clinical Probiotic/Prebiotic and Human Microbiome Research (R01 Clinical Trial Optional)" (Funding Opportunity Number PA-18-001) is aimed at moving probiotic and prebiotic research beyond basic discovery and into practical, human-focused testing that can demonstrate clear, measurable benefits. It uses the NIH R01 grant mechanism and allows, but does not require, clinical trials. The central goal is to strengthen the evidence base for probiotic and prebiotic components, as well as combinations of these interventions, by supporting early-stage translational work and human studies that can establish both safety and signals of efficacy.

The announcement has two main purposes. First, it seeks to accelerate translational and clinical Phase I and Phase IIa/b studies that evaluate safety and efficacy of probiotic and prebiotic interventions, with an emphasis on substantiating functional benefits that can be objectively measured. In practice, this means projects should be designed to produce credible evidence that a given probiotic strain, prebiotic substrate, or combined approach leads to a meaningful biological or clinical effect, not just descriptive changes in the microbiome. Second, it emphasizes the need to understand how these interventions work, including the underlying mechanisms of action and why responses differ from person to person. That includes investigating sources of variability such as differences in baseline microbiome composition, host genetics, immune status, diet, environment, and other factors that may influence outcomes.

A defining feature of this FOA is its strong push for interdisciplinary collaboration. The NIH is explicitly calling for teams that bridge multiple scientific domains involved in microbiome and probiotic/prebiotic research. Fields highlighted include nutritional science, microbiology, virology, microecology and microbiome science, genomics, immunology, computational biology, chemistry, and bioengineering. The FOA also encourages integration of omics methods and advanced computational approaches, including modern DNA technologies and analytic strategies that can connect intervention exposure to microbial community changes, host responses, and clinical or functional endpoints. In other words, the opportunity is tailored for projects that combine carefully designed interventions and human studies with deep biological profiling and data-driven interpretation.

The funding scope is intentionally limited with respect to trial phase. While it supports Phase I and Phase IIa/b studies, it explicitly does not support Phase III clinical trials. That boundary signals the program is intended to generate early-to-mid stage evidence and mechanistic understanding, rather than fund large, definitive, late-stage trials intended for broad clinical adoption or regulatory-level confirmation. Applicants planning extensive Phase III-type trials would need to seek other mechanisms more appropriate for large-scale confirmatory testing.

Eligibility is broad and includes a wide range of public and private entities. Eligible applicants listed include state, county, and city governments; special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; and a wide variety of nonprofit organizations (both with and without 501(c)(3) status). The FOA also allows applications from for-profit organizations (other than small businesses) as well as small businesses, reflecting an interest in translational pipelines that may involve product development, formulation, manufacturing, or implementation partnerships. In addition, it explicitly notes other eligible applicants such as 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, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities, meaning foreign organizations can also apply.

Administratively, the opportunity is categorized as a discretionary grant under NIH, and it is associated with multiple CFDA numbers (93.213, 93.279, 93.321, 93.393, 93.865), reflecting the multi-institute and multi-program relevance of microbiome and nutrition-related research across NIH. The record indicates an original closing date of 2018-05-07 and a creation date of 2017-11-01. An award ceiling is not specified in the provided listing, and the expected number of awards is not stated, so prospective applicants would typically need to consult the full NIH FOA text or related institute guidance for budgeting expectations, paylines, and program priorities.

Overall, this FOA is best understood as NIH support for rigorous, early clinical and translational probiotic/prebiotic research that can produce two kinds of outcomes at once: credible evidence of benefit in humans (or strong signals of benefit alongside safety) and a clear mechanistic story explaining how and why the intervention works, including why it may work well for some people and not others. It is positioned for projects that are ready to move into structured human testing and that can leverage modern microbiome measurement, omics profiling, and computational analysis to translate microbiome science into actionable, health-relevant interventions.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Advancing Translational and Clinical Probiotic/Prebiotic and Human Microbiome Research (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.279, 93.321, 93.393, 93.865.
• This funding opportunity was created on 2017-11-01.
• Applicants must submit their applications by 2018-05-07. (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.

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