Study of Gut-Brain Communication in Parkinsons Disease Including Matched Household Controls and Prodromal Participants

What this Trial Is About

Researchers are studying how the gut-brain axis, the network of nerves connecting the brain and gut, is involved in Parkinsons disease PD. This observational study includes people with varying severity of PD, those at risk for PD, and people without the disease, aiming to compare gut-brain connections among these groups. The goal is to understand gastrointestinal symptoms onset and changes in communication between the gut and brain that may influence PD development and progression. Participants will be grouped into cohorts people with PD classified as mild, moderate, or severe, individuals showing early signs of PD prodromal, and matched household controls without PD. The study involves comprehensive clinical assessments and biospecimen collection, including blood, stool, saliva, skin samples, and colon tissue biopsies. Participants will undergo specialized tests such as swallowing X-rays, colon transit studies, anorectal manometry, and balloon expulsion tests. Biospecimens are collected and sent to Duke University for storage and future research. Participation lasts up to 24 months with evaluations at baseline, 6, 12, 18, and 24 months. During these visits, participants meet with medical providers, complete questionnaires, and provide biological samples. The study measures gastrointestinal and neurological functions and tracks changes over time to identify gut-based biomarkers and better characterize PD symptoms. Safety and compliance are monitored throughout, with the study aiming to improve diagnosis and care for PD patients.

GBPDC: Gut-Brain in PD Consortium Master Protocol