Objective: Describe the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) multicenter (UO1) Consortium on PD Gut-Brain Communication.

Background: A 2024 Notice of Funding Opportunity invited applications for a new PD Gut-Brain Communication Consortium. The stated objective is to “enhance understanding of the temporal onset of Gastrointestinal (GI) symptoms in PD and changes in Gut-Brain Communication that can be used to leverage the potential role of the GI tract in the pathogenesis and progress of PD and to improve patient diagnosis, care and outcomes.”

Method: Reviewed applications were ranked following UO1 protocol standards with the plan to fund up to six GI/Neurology Research Centers (GNRC) and one Coordination and Data Management Center (CDMC) to design and implement an across-center master protocol, with added single-center projects that could involve more than one center.

Results: Rush U, U Chicago, Mayo Clinic, Mass Gen Hosp, and Stanford U are awarded as GNRCs and Duke Clinical Research Institute is the CDMC for the five year contract (2024-2029). The master protocol involving all centers will include PD subjects with mild, moderate or severe PD with mild, moderate or severe GI problems. A prodromal PD group will be included. Participants will be evaluated cross-sectionally and longitudinally with clinical, blood, saliva, stool and colonic mucosa (obtained by sigmoidoscopy) analyses to define microbiome, metabolomic, cellular and molecular differences, anorectal motility, gastric emptying, gut transit time patterns and other key interactions between the GI systems and PD. Proposed center-specific studies include sleep/circadian rhythm impact on gastric dysmotility (MGH, ); omic- and exposome-based signatures of gut/brain dysfunction (Mayo, Rush); novel microbiome functional technologies analyzing gut microbial membership/function, swallowing function, and longitudinal disease progression (U Chicago); altered gut immune mechanisms (Stanford, Rush); gut organoids (Rush), bidirectional circuits of brain-gut-brain and longitudinal disease progression (Rush). Four subcommittees manage the program with NIH oversight: Protocol Development, Data Management, Biorepository, and Publications.

Conclusion: This five-year government support will foster translational research efforts that leverage team science to address key biological and clinical issues relative to the Gut-Brain Axis in PD.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/nih-funds-gut-brain-parkinsons-disease-consortium/