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NCT06848192Withdrawn

The Parkinson's Disease Case-Control Study

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

Source: ClinicalTrials.gov · Last updated 29 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Withdrawn
Study type
Observational
Enrollment
0 (actual)
First submitted
19 Feb 2025
Start date
5 Mar 2025
Primary completion date
1 Dec 2025
Lead sponsor
Westlake University
NCT number
NCT06848192

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous MRI scans showed clinically significant neurological disorders (as judged by the investigator).
  • Antibiotics have been used within 3 months prior to sample collection.
  • 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.
  • Antibiotics have been used within 3 months prior to sample collection.

Other illness

  • 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.
  • 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.
  • 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).
  • 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.

Other

  • (For PD patients)
  • Chronic constipation.
    • (For healthy volunteers)
  • Chronic constipation.
  • Participating in other clinical trials

Who the study is looking for

  • (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.

Age in the registry: 50 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.