Limited Competition for the Continuation of Clinical Centers to Investigate the Pathogenesis, Etiology, and Treatment of Gastroparesis through the NIDDK Gastroparesis Consortium (U01 Clinical Trial Optional) | RFA DK 20 504

Opportunity Information: Apply for RFA DK 20 504

This funding opportunity (RFA DK 20 504) is a limited-competition NIH notice from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) that supports the continuation of established clinical centers within the NIDDK Gastroparesis Clinical Research Consortium (GPCRC, previously referenced as GPRCR). It is designed specifically to keep the existing consortium infrastructure operating so it can continue investigating gastroparesis, with an emphasis on understanding disease mechanisms (pathogenesis and etiology) and improving treatment through well-coordinated multi-site research. Because it is a limited competition, the intent is not to open a new national network of sites, but to fund ongoing work at clinical sites that have already been participating in the consortium.

A central goal is to sustain and expand the consortiums active patient cohorts and research platforms, including continued support for the first U.S. registry focused on children and adolescents with gastroparesis. Maintaining these cohorts matters because gastroparesis is relatively complex and heterogeneous, and long-term, systematically collected data across multiple sites can help clarify how symptoms, gastric emptying, comorbidities, and treatment responses vary across patients over time. The FOA also emphasizes enabling ongoing clinical trials and providing a stable platform for ancillary studies, meaning additional investigator-driven projects that can leverage the cohorts, data systems, and coordinated operations already in place.

A major collaborative deliverable highlighted in the announcement is the creation of an annotated biospecimen repository. The repository is expected to include blood and stool samples and, when feasible, gastric tissue. The term annotated signals that specimens are meant to be linked to well-characterized clinical information (for example, participant demographics, symptoms, clinical course, physiologic testing results, medication exposure, and outcomes). This combined resource is intended to accelerate biomarker discovery and validation, including biomarkers that could be useful for risk stratification (identifying which patients are likely to have more severe disease or worse outcomes) and for earlier detection. In practical terms, the repository is meant to make it easier for the consortium to connect biologic signals with clinical phenotypes and potentially identify subtypes of gastroparesis that respond differently to therapies.

The FOA also explicitly notes that the consortium will build on the ongoing Pathological Basis of gastroparesis study, reflecting a priority on better defining the underlying tissue- and cellular-level changes associated with the condition. By strengthening the pathological and biologic foundations, the program aims to move beyond symptom-based descriptions toward a clearer understanding of disease mechanisms, which is often necessary to develop targeted therapies and improve trial design.

From an administrative standpoint, this opportunity uses a cooperative agreement mechanism (U01), which typically means NIH has substantial scientific and programmatic involvement in the conduct of the work, consistent with a coordinated, multi-site consortium model. The activity falls under health-related research (CFDA 93.847) and is categorized within discretionary funding. The listing provides an award ceiling of $250,000, and the original closing date for applications was December 16, 2020 (creation date September 24, 2020), indicating this specific announcement reflects a defined historical application cycle.

Eligibility is restricted in a way that matches the limited-competition intent. Applications are invited from the clinical sites that have participated in the NIDDK Gastroparesis Clinical Research Consortium. The FOA also notes additional eligible applicant categories such as eligible agencies of the U.S. federal government and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply as applicant organizations, but non-domestic components of U.S. organizations may participate, and foreign components are allowed as defined by the NIH Grants Policy Statement. This structure allows the consortium to incorporate specific international expertise or resources through foreign components while keeping the primary award and governance anchored in eligible U.S.-based organizations.

Overall, the opportunity is best understood as continued support for an established national clinical research infrastructure focused on gastroparesis: preserving and extending existing cohorts (including a pediatric and adolescent registry), enabling multi-site clinical trials, supporting add-on studies, and creating shared biospecimen resources linked to deep clinical data. The larger aim is to speed progress toward mechanistic understanding, biomarker development, and better therapeutic strategies for gastroparesis through coordinated consortium-based research.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition for the Continuation of Clinical Centers to Investigate the Pathogenesis, Etiology, and Treatment of Gastroparesis through the NIDDK Gastroparesis Consortium (U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2020-09-24.
• Applicants must submit their applications by 2020-12-16. (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 $250,000.00 in funding.
• Eligible applicants include: Others.

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