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).
Aged ≥21 years old and ≤80 years old
Clinical diagnosis of PD as defined by Movement Disorder Society (MDS) PD Criteria
Adequate visual, hearing, cognitive, and physical ability
Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures. Because longitudinal participation is important to the scientific goals of the program, a "best estimate" of interest, commitment, and geographic feasibility for three years will be documented by the enrolling investigator after interview with the potential enrollee
Diagnosis of secondary or atypical parkinsonism
Hemoglobin (Hgb) <10
Platelets <70,000
Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) > 2 1/2 times upper limit of normal (ULN)
Patients at the NIDDK designated Gastroenterology Neurology Research Centers
Cohort
Prospective
Not listed
GI influences on PD
Trait and State cross-sectional evaluation of GI influences on PD
Co-associations components of the GBA
Cross-sectional co-associations components of the GBA
GBA Disruption and Parkinson's disease Progression
GBA disruption triggered by microbiota dysbiosis (or another GI component of the GBA) predicts PD progression (both motor and non-motor dysfunction/symptoms including GI over time).
GBA Disruption and Prodromal Participants
Degree of the "type" or "nature" or "form" of the GBA disruption predict development of PD in prodromal participants over time.
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Chicago
Collaborator
Rush University Medical Center
Collaborator
Massachusetts General Hospital
Collaborator
Stanford University
Collaborator
Medical University of South Carolina
Collaborator
Columbia University
Collaborator
Mayo Clinic
Collaborator
