GBPDC: Gut-Brain in PD Consortium Master Protocol

The purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study. During this study, specific groups of participants, also known as "cohorts", will be identified based on the severity of their PD. There will also be a cohort enrolling participants who do not have Parkinson's and a cohort enrolling participants that are at risk for developing PD. Each of these cohorts will be compared to the others to assess the differences in the gut-brain connection. Participants in this study will: * meet with a medical provider * answer questionnaires * give samples of blood, stool, and saliva * have X-rays taken while swallowing different foods (swallowing study) * have X-rays taken to see how long it takes markers to move through their colon (colon transit study) * have a flexible sigmoidoscopy, where a doctor looks inside the lower part of the colon and takes small tissue samples (biopsies) from the mucosa (lining) * have samples taken of their skin * have an anorectal manometry and a balloon expulsion test, where a small tube and balloon are placed in the rectum to measure muscle function. Participation in the study will last up to 24 months (2 years).

NCT Number	NCT07567794
Lead Sponsor	Duke University Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Chicago, Rush University Medical Center, Massachusetts General Hospital, Stanford University, Medical University of South Carolina, Columbia University, Mayo Clinic
Conditions	Parkinson Disease (PD), PARKINSON DISEASE (Disorder), Gut Microbiome, Gut Microbiota, Prodromal Parkinsons Disease
Enrollment	250 participants
Start Date	2026-07-03
Primary Completion	2028-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-31