GBPDC: Gut-Brain in PD Consortium Master Protocol

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).

Conditions

• Parkinson Disease (PD)
• PARKINSON DISEASE (Disorder)
• Gut Microbiome
• Gut Microbiota
• Prodromal Parkinsons Disease

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Chicago

  collaborator OTHER

• Rush University Medical Center

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• Lisa Wruck · Duke Clinical Research Institute

Eligibility

Min Age

21 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-06-04

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• United States

Study Locations