Opportunity Information: Apply for PA 15 127
Apply for PA 15 127
- 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)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213 Research and Training in Complementary and Integrative Health 93.279 Drug Abuse and Addiction Research Programs 93.321 Dietary Supplement Research Program 93.393 Cancer Cause and Prevention Research 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Feb 26, 2015 and posted on Feb 26, 2015.
- Applicants must submit their applications by May 7, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Private institutions of higher education Native American tribal governments (Federally recognized) City or township governments State governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) County governments.
- 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.
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Opportunity Summary:
The NIH grant opportunity "Advancing Translational and Clinical Probiotic/Prebiotic and Human Microbiome Research (R01)" (Funding Opportunity Number PA-15-127) is designed to push probiotic and prebiotic research beyond basic discovery and toward real-world, clinically meaningful evidence. Its core aim is to fund projects that can demonstrate measurable functional benefits of probiotic and/or prebiotic components (including combinations), while also explaining how those benefits happen biologically and why different people may respond differently. The announcement is centered on translational and early-stage clinical work, specifically supporting Phase I and Phase II a/b studies that focus on safety, tolerability, and early evidence of efficacy in humans. It explicitly does not support Phase III clinical trials, so it is not intended for large-scale definitive efficacy studies meant to change clinical practice on their own, but rather the earlier clinical steps that justify and inform those larger trials.
A major theme of this FOA is integration: applicants are expected to bring together interdisciplinary expertise and modern measurement approaches to connect an intervention to a functional outcome and a plausible mechanism. The NIH emphasizes collaborations spanning fields such as nutritional science, microbiology and virology, microecology and microbiome science, genomics, immunology, computational biology, chemistry, and bioengineering. It also highlights the use of omics and computational approaches, including DNA-based technologies, which signals strong interest in studies that do more than track symptoms or clinical endpoints alone. Competitive projects under this program would typically link clinical readouts (for example, markers of inflammation, metabolic function, gastrointestinal outcomes, or other health-relevant endpoints) with microbiome-related changes and host responses, and then analyze those links in a way that clarifies mechanism and predicts variability in response across individuals or subgroups.
From an administrative standpoint, this is a discretionary grant using the NIH R01 mechanism, meaning it is intended for substantial, hypothesis-driven research programs that can include human studies when justified. The announcement lists multiple related CFDA numbers across complementary and integrative health, drug abuse and addiction, dietary supplement research, cancer cause and prevention, and child health and human development, which reflects that microbiome, probiotic, and prebiotic interventions can be relevant across a broad range of health conditions and populations. There is no cost-sharing or matching requirement, reducing barriers for applicants who may not have institutional matching funds available.
Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses, though small businesses are also listed separately as eligible), and a wide range of government entities such as state, county, city/township, special district governments, and independent school districts. The FOA also explicitly includes tribal governments and tribal organizations, public housing authorities/Indian housing authorities, and an extensive set of institution types such as HBCUs, Hispanic-serving institutions, AANAPISISs, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities, and U.S. territories or possessions. It also allows non-domestic (foreign) entities and regional organizations, indicating NIH interest in enabling strong microbiome and intervention science regardless of geography when scientifically justified.
The opportunity was posted on February 26, 2015, with an original and final closing date of May 7, 2018, and it was archived on June 7, 2018. Even though it is archived, the summary still captures what NIH was seeking: well-designed early-phase clinical and translational studies of probiotics and prebiotics that quantify functional benefit, establish safety and preliminary efficacy, and pair those outcomes with mechanistic insight and an explanation of response variability using interdisciplinary methods and modern multi-omics and computational tools. The full announcement was hosted on the NIH Grants Guide (PA-15-127), and NIH provided contact points through the NIH Office of Extramural Research webmaster for access or linking issues.
Frequently Asked Questions (FAQs)
What is the name of this NIH funding opportunity?
The opportunity is titled "Advancing Translational and Clinical Probiotic/Prebiotic and Human Microbiome Research (R01)" and is associated with Funding Opportunity Number (FON) PA-15-127.
What is the main purpose of PA-15-127?
The main purpose is to move probiotic and prebiotic research beyond basic discovery and toward clinically meaningful, real-world evidence. The FOA emphasizes projects that can (1) demonstrate measurable functional benefits of probiotic and/or prebiotic components (including combinations), and (2) explain plausible biological mechanisms for those benefits, including why different people may respond differently.
What kinds of studies does this FOA emphasize?
The announcement centers on translational and early-stage clinical research, specifically Phase I and Phase II a/b studies in humans. These studies are expected to focus on safety, tolerability, and early evidence of efficacy.
Are Phase III clinical trials allowed under this FOA?
No. The FOA explicitly does not support Phase III clinical trials. It is intended for earlier clinical steps that help justify and inform later, larger definitive trials, rather than serving as the final practice-changing study on its own.
What types of interventions are in scope?
The FOA focuses on probiotic and/or prebiotic components, including combinations of the two. Projects are expected to connect the intervention to functional outcomes and to biological mechanisms.
What does NIH mean by "functional benefit" in this context?
Based on the FOA summary, "functional benefit" refers to measurable, health-relevant outcomes in humans. Examples mentioned include markers of inflammation, metabolic function, gastrointestinal outcomes, and other clinically meaningful endpoints.
What does NIH expect regarding mechanisms of action?
NIH expects applicants to pair functional outcomes with a plausible biological explanation of how the intervention produces the observed benefit. Competitive projects would typically link clinical readouts to microbiome-related changes and host responses in a way that clarifies mechanism.
Does the FOA address differences in how individuals respond to probiotics or prebiotics?
Yes. A core emphasis is understanding and explaining response variability across individuals or subgroups. Projects are expected to analyze why different people may respond differently and, where possible, improve prediction of that variability.
What kinds of scientific approaches are encouraged?
The FOA highlights integration of modern measurement approaches, including omics and computational methods, and specifically signals interest in DNA-based technologies. The intent is to support studies that go beyond tracking symptoms alone and instead connect interventions to mechanistic and host-response data.
Is interdisciplinary collaboration expected?
Yes. The FOA emphasizes bringing together interdisciplinary expertise. Examples of relevant fields include nutritional science, microbiology and virology, microecology and microbiome science, genomics, immunology, computational biology, chemistry, and bioengineering.
What is the funding mechanism used for this opportunity?
This is an NIH discretionary grant using the R01 mechanism. R01s are intended for substantial, hypothesis-driven research programs and can include human studies when justified.
Is this opportunity limited to one disease area or population?
No. The announcement references multiple related CFDA areas (including complementary and integrative health, drug abuse and addiction, dietary supplement research, cancer cause and prevention, and child health and human development). This reflects that microbiome, probiotic, and prebiotic interventions can be relevant across many health conditions and populations.
Is cost sharing or matching required?
No. The FOA states there is no cost-sharing or matching requirement, which can reduce barriers for applicants without institutional matching funds.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include public and private institutions of higher education; nonprofits (501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses, though small businesses are also listed as eligible); and many government entities (state, county, city/township, special district governments, and independent school districts).
Are tribal entities eligible?
Yes. The FOA explicitly includes tribal governments and tribal organizations, as well as public housing authorities/Indian housing authorities.
Are minority-serving institutions and U.S. territories included in eligibility?
Yes. The FOA lists a wide range of institution types, including HBCUs, Hispanic-serving institutions, AANAPISISs, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities, and entities in U.S. territories or possessions.
Can non-U.S. (foreign) organizations apply?
Yes. The FOA allows non-domestic (foreign) entities and regional organizations, indicating support for strong microbiome and intervention science regardless of geography when scientifically justified.
What are the key dates for this funding opportunity?
The opportunity was posted on February 26, 2015. The original and final closing date was May 7, 2018. It was archived on June 7, 2018.
What does it mean that this FOA is archived?
Based on the provided information, "archived" indicates the opportunity is no longer active for submission under that announcement. The archived summary still describes what NIH sought to fund during the open period: early-phase clinical and translational probiotic/prebiotic microbiome studies with measurable benefit, safety and preliminary efficacy data, and mechanistic insight including response variability.
Where was the full announcement hosted?
The full announcement was hosted on the NIH Grants Guide under PA-15-127.
Who was listed as a contact for access or linking issues?
NIH provided contact points through the NIH Office of Extramural Research webmaster for access or linking issues related to the announcement.
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