The Parkinson's Disease Case-Control Study

NCT06848192 | Recruiting

• 1 other identifier: 20250115ZJS001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Gut microbiome profiling

  The microbiome profile is analyzed based on stool samples.

  At enrollment

Secondary Outcomes (3)

• Fecal and serum metabolomics profiling

  At enrollment

• Blood and urine proteomics profiling

  At enrollment

• Brain imaging features

  At enrollment

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the participants should be residents living in Hangzhou, China

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).

Sponsors & Collaborators

• Westlake University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Biospecimen

Blood (10 mL), stool sample (10 g), random midstream urine (12 mL)

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Ju-Sheng Zheng, PhD

CONTACT

86-0571-86915303; zhengjusheng@westlake.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 26, 2025
• Study Start: March 5, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-03

Locations

CN (1)