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Recruiting NCT06848192

The Parkinson's Disease Case-Control Study

— Observational Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 50 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Parkinson's Disease Case-Control Study: Gut Microbiome Study for Parkinson's Disease

Overview

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.

Detailed description

Parkinson's disease is the second most common neurodegenerative disease of the central nervous system. Recent studies have shown that gut microorganisms, through their metabolites, can directly and indirectly affect brain function and neurodegenerative processes through the immune system, endocrine system, and nervous system, thus affecting the progress of Parkinson's disease. Gut fungi, as an important component of gut microorganisms, are rarely studied in Parkinson's disease. To systematically explore the differences in intestinal fungi between patients with Parkinson's disease and healthy volunteers, this project is expected to recruit 20 healthy volunteers and 20 Parkinson's disease patients respectively. The Parkinson's Disease Case-Control Study design incorporates collecting demographic information and clinical characteristics of Parkinson's disease patients and healthy volunteers, as well as biological samples (blood, urine, stool) and brain magnetic resonance imaging (MRI) of the subjects.

Primary outcome measures

  • Gut microbiome profiling [Time frame: At enrollment]
Secondary outcome measures (3)
  • Fecal and serum metabolomics profiling [Time frame: At enrollment]
  • Blood and urine proteomics profiling [Time frame: At enrollment]
  • Brain imaging features [Time frame: At enrollment]

Eligibility criteria

Inclusion criteria

(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.

Exclusion criteria

(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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 1 center
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT06848192 · 20250115ZJS001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗