The Parkinson's Disease Case-Control Study
Launched by WESTLAKE UNIVERSITY · Feb 19, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The Parkinson's Disease Case-Control Study is looking at the differences in gut fungi between people with Parkinson's disease and healthy individuals to better understand how these differences might affect the disease. The study will include volunteers aged 50 to 75, both those diagnosed with Parkinson's disease and healthy individuals who are similar in age and gender to the patients. Researchers hope to uncover important information about how the gut and brain interact, which could lead to new insights into Parkinson's disease.
To participate, patients need to have a clinical diagnosis of Parkinson's disease and show at least two specific symptoms, like tremors or stiffness. Healthy volunteers must be matched in age and gender to a patient but cannot have a family history of Parkinson's or significant neurological disorders. Participants can expect to provide consent and may undergo tests and assessments related to their gut health and brain function. This study is important as it aims to contribute to our understanding of Parkinson's disease and could help in developing future treatments.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • (For PD patients)
- • 1. Men or women aged 50 to 75 years.
- • 2. Clinical diagnosis of Parkinson's disease (based on MDS Parkinson's disease diagnostic criteria)
- • 3. The patient must have at least two of the following symptoms: static tremor, bradykinesia, stiffness (which must include at least static tremor or bradykinesia); Or have asymmetrical resting tremors or asymmetrical bradykinesia.
- • 4. Able to provide informed consent.
- • (For healthy volunteers)
- • 1. Age (±2 years) and sex-matched healthy control individuals for each Parkinson's disease patient.
- • 2. Able to provide informed consent.
- Exclusion Criteria:
- • (For PD patients)
- • 1. Atypical or secondary parkinsonism due to medications (e.g., metoclopramide, flunarizine, antipsychotics) or metabolic diseases (e.g., Wilson's disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).
- • 2. The presence of clinically diagnosed dementia as determined by the investigator.
- • 3. Previous MRI scans showed clinically significant neurological disorders (as judged by the investigator).
- • 4. Serious illness (e.g., heart failure or malignancy).
- • 5. Smoking more than 15 cigarettes a day and a history of alcohol or drug addiction
- • 6. Inflammatory gastrointestinal diseases.
- • 7. Chronic diseases that may affect the gut microorganism (e.g., diabetes, cirrhosis, or cardiovascular disease).
- • 8. Blood or autoimmune disease, or use of immunosuppressants in the past 3 months.
- • 9. Antibiotics have been used within 3 months prior to sample collection.
- • 10. Chronic constipation.
- • (For healthy volunteers)
- • 1. Have a first-degree relative with Parkinson's disease (e.g. biological parent, sibling, or child).
- • 2. Current or past clinically significant neurological disorders (as judged by the investigator).
- • 3. Previous MRI scans showed clinically significant neurological disorders (as judged by the investigator).
- • 4. Use of the following drugs in the 6 months prior to the screening visit: dopamine blockers (antipsychotics), metoclopramide, and riserpine.
- • 5. Inflammatory gastrointestinal diseases.
- • 6. Smoking more than 15 cigarettes a day and a history of alcohol or drug addiction
- • 7. Chronic diseases that may affect the gut microorganism (e.g., diabetes, cirrhosis, or cardiovascular disease).
- • 8. Blood or autoimmune disease, or use of immunosuppressants in the past 3 months.
- • 9. Antibiotics have been used within 3 months prior to sample collection.
- • 10. Chronic constipation.
- • 11. Participating in other clinical trials
About Westlake University
Westlake University is a leading research institution dedicated to advancing scientific knowledge and innovation in the life sciences. With a commitment to excellence in research and education, Westlake University engages in pioneering clinical trials that aim to explore new therapeutic interventions and improve patient outcomes. By fostering collaboration among multidisciplinary teams and leveraging state-of-the-art facilities, the university is at the forefront of transformative medical research, contributing valuable insights to the global healthcare community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hangzhou, Zhejiang, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported