The NIDDK Disorders of Gastrointestinal Interoception Consortium Clinical Centers (DGIC)

The National Institute of Diabetes and Digestive Diseases and Nutrition (NIDDK) seeks to advance its mission by continuing the work of the NIDDK Gastroparesis Consortium (GpCRC) but also to expand its scope. The collaborative efforts of the GpCRC provided a large database, the Gastroparesis Registry, which is located in the NIDDK central repository and contains information on patients with symptoms of either delayed or normal gastric emptying. It also houses the first U.S. registry of children and adolescents with gastroparesis. The GpCRC provided clarity and insight that set the stage for transforming our understanding of gastroparesis and laid out a road map for approaching other disorders of gastrointestinal (GI) motility. The findings from clinical studies and trials clearly demonstrated that the clinical burden of gastroparesis is significantly greater than previously realized and involves much more than the stomach. Importantly, the underlying mechanisms remain unclear. Interoception is the ability of the nervous system to sense, interpret and coordinate signals from various bodily systems including the GI tract. Many functional GI disorders are associated with a spectrum of overlapping symptoms including nausea, vomiting, and altered bowel habits all of which involve altered interoceptive signaling. This initiative would broaden the scope beyond gastroparesis to include other adult and pediatric GI conditions associated with impaired interoceptive processing to form a Disorders of Gastrointestinal Interoception Consortium (DGIC). The consortium may include up to 6 Clinical Research Centers (described in a companion notice) and a Scientific Data Research Center (SDRC). There would be an emphasis on multidisciplinary approaches that would reveal the underlying mechanisms that connect GI function more directly to symptoms, identify disease or response biomarkers that assess treatment efficacy, and leverage state-of-the-art technologies to identify novel therapeutic targets that could be assessed in future clinical trials. The SDRC will coordinate collaboration among the Clinical Research Centers, participant enrollment, biospecimen collections and processing, and manage the submission of data and samples to central databases and repositories.

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...