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).
Who can participate
Age range21 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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
✓. Aged ≥21 years old and ≤80 years old
✓. No known or diagnosed neurodegenerative disease
✓. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures
✓. Resides within the same household as person with PD
Exclusion criteria
✕
What they're measuring
1
GI influences on PD
Timeframe: enrollment to end of observation at 24 months
2
Co-associations components of the GBA
Timeframe: enrollment to end of observation at 24 months
✕. Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) \> 2 1/2 times upper limit of normal (ULN)
✕. Moderate or severe renal disease with an estimated glomerular filtration rate (eGFR) \<60 mL/min/BSA \[body surface area\]) calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation, or moderate or severe hepatic impairment (alkaline phosphatase \[ALP\] \>2.0 times the ULN and/or total bilirubin \>2.0 times the ULN)
✕. Significantly above the normal range for PT/INR/PTT
✕. Currently taking anticoagulants that are deemed exclusionary by the investigator for risk of bleeding with sigmoidoscopy procedure