Objective: To describe the master protocol and timeline for the multicenter Gut-Brain Communication in Parkinson’s Disease Consortium (GBPDC), funded by NIDDK/NIH (UO1) from 2024 to 2029.

Background: This Consortium aims to improve the understanding of the gut-brain communication in PD pathogenesis and progression, with potential implications for diagnosis and treatment.

Method: Participating Gastroenterology (GI)/Neurology Research Centers (Rush University/MUSC, University of Chicago, Mayo Clinic, Massachusetts General Hospital/Columbia University, and Stanford University), Coordination and Data Management Center (Duke Clinical Research Institute), and NIDDK/NIH worked jointly to develop the cross-center master protocol and timeline.

Results: • We plan to enroll 250 individuals aged 21-80, including 150 PD patients with mild (~50 patients, Hoehn-Yahr (HY) stage 1-2, PD medication naïve), moderate (~50, HY stage 1-2, on medication), or advanced stage (~50, HY stage 3-5, on medication), as well as 50 age-matched healthy household controls, and 50 individuals with prodromal features (hyposmia/anosmia and RBD).

• Participants of all groups will have in-person visits during the Screening, Baseline (BL), Months 12 and 24 of the study, and in-person or virtual visits at Months 6 and 18.

• Information will be collected cross-sectionally and longitudinally, on parkinsonian motor and non-motor features in PD group (at every visit from BL to Months 24), GI investigations by procedures (anorectal manometry, colon transit, flexible sigmoidoscopy with mucosal biopsies, and videofluoroscopic swallow study) in all groups (at BL and Months 24), biospecimen (stool, blood, saliva, and sigmoid mucosa), questionnaires or diaries on other motor and non-motor features, GI function, dietary and physical activities in all groups (at BL, Months 12 and 24), and skin biopsy for alpha-synuclein protein in prodromal group (at BL).

• Four subcommittees oversee protocol development, data collection, biorepository samples, and publications, under NIDDK/NIH oversight. 

• We will compare clinical features, GI microbiome and mucosal transcriptome and synuclein profiles, swallow function, and colon transit and anorectal function in patients with PD, prodromal PD, and controls.

Conclusion: The master protocol and timeline developed will leverage team science to address key biological and clinical issues relative to the gut-brain axis in PD.

References: None

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MDS Abstracts - https://www.mdsabstracts.org/abstract/nih-multicenter-consortium-for-gut-brain-communication-in-parkinsons-disease-the-master-protocol-and-timeline/