RecruitingNCT07567794

GBPDC: Gut-Brain in PD Consortium Master Protocol

Consortium for Gut-Brain Communication in Parkinson's Disease Master Protocol


Sponsor

Duke University

Enrollment

250 participants

Start Date

Jul 3, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Min Age: 21 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with gut microbiome, gut microbiota, and other related conditions. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(7)

Stanford University

Stanford, California, United States

Rush University

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Columbia University

New York, New York, United States

Medical University of South Carolina

Charleston, South Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT07567794


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