A Consortium for Gut-Brain Communication in Parkinsons Disease (U01 Clinical Trial Not Allowed) | RFA DK 22 036

Opportunity Information: Apply for RFA DK 22 036

The NIH funding opportunity RFA-DK-22-036 supports the creation of a coordinated, multi-site research consortium focused on how gastrointestinal (GI) symptoms and gut-brain communication may contribute to the earliest stages and underlying biology of Parkinsons disease (PD). Using the U01 cooperative agreement mechanism (clinical trial not allowed), the program is designed to bring multiple clinical research projects together with a central Coordinating Center so that participating sites operate as a single, standardized network rather than as isolated studies. The overall aim is to speed up progress on GI-related pathways in PD and translate that progress into practical, early-phase diagnostic approaches and biomarkers that are grounded in GI biology and gut-brain signaling.

At the heart of the initiative is a push for well-powered, harmonized clinical research. The consortium is expected to recruit enough participants across sites to enable meaningful comparisons and robust analyses, while using shared protocols for collecting clinical data and biospecimens that matter to both neurology and gastroenterology research. The research centers will function as enrollment and sampling sites for several key groups: people with Parkinsons disease who do and do not have GI symptoms, individuals who have GI symptoms thought to place them at higher risk for developing PD, and healthy age-matched control participants. Samples and clinical information gathered from these groups are intended to support laboratory-based investigations that clarify mechanisms, identify measurable biological signals, and strengthen or refute proposed gut-brain links in PD initiation and progression.

A major expectation is broad sharing and public availability of what the consortium generates. Beyond typical publication, the program emphasizes that data, biomaterials, models, reagents, resources, and methods should be shared among consortium projects and then made accessible to the wider scientific community through the Coordinating Center. In practice, this means the consortium is expected to operate with a strong team-science mindset: common data elements, standardized biospecimen handling, consistent clinical phenotyping, and coordinated governance that enables rapid internal exchange and eventual external dissemination. The goal is to create resources that other investigators can reuse and build on, reducing duplication and making findings easier to validate across cohorts and settings.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is a key NIH institute behind the effort, reflecting the strong GI component and the need to integrate digestive health expertise with movement-disorders neurology. The FOA also highlights NIH priorities around inclusive and representative research. Applicants are strongly encouraged to incorporate research on sex and gender differences, sexual and gender minority-related research, and race and ethnic diversity, aligning with NIDDK guidance (referenced as NOT-DK-22-003). This emphasis signals that the consortium should be designed to capture variation in PD presentation and GI symptoms across populations, and to ensure that any resulting diagnostic tools or biomarkers are more likely to generalize and avoid widening existing health disparities.

From an administrative standpoint, this is a discretionary NIH opportunity using the cooperative agreement model, which typically involves substantial NIH scientific and programmatic involvement compared with standard investigator-initiated grants. The activity sits broadly within health and nutrition-related categories and is associated with CFDA number 93.847. The posted award ceiling is $300,000, with an original closing date of 2023-11-15 and a creation date of 2023-07-31. Because it is labeled "Clinical Trial Not Allowed," applications should focus on clinical research and human participant studies that do not meet NIH’s definition of a clinical trial (for example, they should not prospectively assign participants to interventions to evaluate health-related outcomes), while still allowing rigorous observational, mechanistic, and biomarker-focused work in clinically characterized cohorts.

Eligibility is broad and includes many domestic organization types such as state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities. The FOA also explicitly calls out categories of organizations that are encouraged or included as eligible applicants, such as HBCUs, Hispanic-serving institutions, AANAPISIs, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, the opportunity limits foreign participation: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S.-led application may still include certain allowable foreign elements when justified and compliant with NIH policy.

Overall, the opportunity is best understood as an NIH-driven effort to unify clinical cohort building, GI and neurologic phenotyping, biospecimen collection, and open-resource generation around a specific hypothesis space: that PD may be initiated or shaped by GI dysfunction and altered gut-brain communication, and that these signals could be leveraged for earlier detection and better biomarkers. The consortium structure is intended to make studies larger, more comparable, and more reusable than typical single-site projects, while accelerating the field through coordinated operations and required data and resource sharing.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "A Consortium for Gut-Brain Communication in Parkinsons Disease (U01 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): 93.847.
• This funding opportunity was created on 2023-07-31.
• Applicants must submit their applications by 2023-11-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $300,000.00 in funding.
• 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 DK 22 036

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