Advancing Translational and Clinical Probiotic/Prebiotic and Human Microbiome Research (R01 Clinical Trial Optional) | PA 18 902

Opportunity Information: Apply for PA 18 902

Advancing Translational and Clinical Probiotic/Prebiotic and Human Microbiome Research (R01 Clinical Trial Optional) is a National Institutes of Health (NIH) discretionary grant opportunity (Funding Opportunity Number: PA 18-902) designed to move probiotic, prebiotic, and related microbiome-based interventions closer to real-world clinical and public health use. The program is focused on translational and early-stage clinical research rather than basic discovery alone, with the overall aim of producing stronger evidence for measurable, functional benefits in humans while also explaining how and why those benefits occur.

The FOA has two main goals. First, it seeks to accelerate Phase I and Phase II a/b studies that evaluate safety and early efficacy of probiotic and prebiotic components, including combinations of these components. In practical terms, NIH is looking for well-designed early clinical investigations that can substantiate functional outcomes, such as changes in physiological measures, symptoms, biomarkers, or other clinically meaningful endpoints that indicate a benefit linked to the intervention. Second, the FOA emphasizes mechanistic understanding and the sources of variability in response. That means projects are expected not only to test whether an intervention works and is safe, but also to probe the biological pathways involved and to address why different individuals or groups may respond differently, including factors related to microbiome composition, host genetics, immune status, diet, environment, or other covariates.

A defining feature of this funding opportunity is its push for interdisciplinary teamwork. NIH explicitly encourages collaborations that span microbiome and probiotic/prebiotic research areas such as nutritional science, microbiology, virology, microbial ecology and microbiome science, genomics, immunology, computational biology, chemistry, and bioengineering. The FOA also highlights the value of integrating omics approaches and computational methods, including DNA-based technologies, to connect clinical outcomes to microbiome changes, microbial functions, host responses, and other mechanistic readouts. In other words, the program is positioned for projects that combine clinical study design with modern analytical platforms to generate interpretable, reproducible evidence.

This is an R01 mechanism, which generally supports substantial, multi-year research projects, and it is labeled "Clinical Trial Optional," meaning applications may include a clinical trial if appropriate but are not required to do so. Importantly, the FOA specifically does not support Phase III clinical trials. Applicants should interpret this as a clear boundary: the program is aimed at early human testing and translational work (including Phase I and Phase II a/b) rather than large-scale, definitive efficacy trials intended for broad clinical adoption.

Eligibility is broad and includes many types of organizations that can propose and conduct rigorous translational or clinical research. Eligible applicants listed include 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 tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities. The FOA also explicitly calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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, non-U.S. entities (foreign organizations), and U.S. territories or possessions. This wide eligibility reflects NIH's intent to draw on diverse institutional strengths and community contexts, especially where microbiome-related interventions may have population-specific relevance.

From the program metadata, the opportunity sits within health and education activity categories and references CFDA numbers 93.213, 93.321, and 93.393. The FOA was created on 2018-08-14, and the original closing date listed is 2021-09-07. The award ceiling and expected number of awards are not specified in the provided source data, which typically means applicants would need to consult the full FOA text or NIH guidance for budget expectations, institute-specific interests, and any funding limits or typical award sizes.

Overall, this NIH FOA is best understood as a pathway for researchers to bring promising probiotic/prebiotic and microbiome-targeted concepts into early clinical testing while generating mechanistic evidence that explains outcomes and individual variability. Competitive projects under this announcement would be expected to pair strong clinical or translational study design with modern microbiome measurement and computational approaches, producing results that can guide future development and, potentially, set the stage for later-stage trials funded through other mechanisms.

• The National Institutes of Health in the education, health 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, 93.321, 93.393.
• This funding opportunity was created on 2018-08-14.
• 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.

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