The Parkinson's Disease Case-Control Study
Recruiting now
Conditions studied: Parkinson Disease
In brief
The Parkinson's Disease Case-Control Study is a study of healthy volunteers and patients with Parkinson's disease aged 50-75 years living in Hangzhou, China. This study aims to systematically investigate the differences in intestinal fungi between patients and healthy volunteers, find the key strains, and explore the molecular mechanism of Parkinson's disease with multi-omics data. Another aim of this study is to explore the association between intestinal fungi and brain structure and function from the perspective of the gut-brain axis by combining brain image data.
Key facts
- Study ID
- NCT06848192
- Run by
- Westlake University
- People needed
- 40
- Starts
- 2025-03-05
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-06-13
Who can join
Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- (For PD patients)
- Men or women aged 50 to 75 years.
- Clinical diagnosis of Parkinson's disease (based on MDS Parkinson's disease diagnostic criteria)
- 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.
- Able to provide informed consent.
- (For healthy volunteers)
- Age (±2 years) and sex-matched healthy control individuals for each Parkinson's disease patient.
- Able to provide informed consent.
You may not qualify if…
- (For PD patients)
- 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).
- The presence of clinically diagnosed dementia as determined by the investigator.
- Previous MRI scans showed clinically significant neurological disorders (as judged by the investigator).
- Serious illness (e.g., heart failure or malignancy).
- Smoking more than 15 cigarettes a day and a history of alcohol or drug addiction
- Inflammatory gastrointestinal diseases.
- Chronic diseases that may affect the gut microorganism (e.g., diabetes, cirrhosis, or cardiovascular disease).
- Blood or autoimmune disease, or use of immunosuppressants in the past 3 months.
- Antibiotics have been used within 3 months prior to sample collection.
- Chronic constipation.
- (For healthy volunteers)
- Have a first-degree relative with Parkinson's disease (e.g. biological parent, sibling, or child).
- Current or past clinically significant neurological disorders (as judged by the investigator).
- Previous MRI scans showed clinically significant neurological disorders (as judged by the investigator).
- Use of the following drugs in the 6 months prior to the screening visit: dopamine blockers (antipsychotics), metoclopramide, and riserpine.
- Inflammatory gastrointestinal diseases.
- Smoking more than 15 cigarettes a day and a history of alcohol or drug addiction
- Chronic diseases that may affect the gut microorganism (e.g., diabetes, cirrhosis, or cardiovascular disease).
- Blood or autoimmune disease, or use of immunosuppressants in the past 3 months.
- Antibiotics have been used within 3 months prior to sample collection.
- Chronic constipation.
- Participating in other clinical trials
Where it is running
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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