Parkinson DiseaseNCT06848192
The Parkinson's Disease Case-Control Study
An observational study of Parkinson Disease, run by Westlake University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All the participants should be residents living in Hangzhou, China
Who may be able to join
- (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.
Who cannot join
- (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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
Official title: The Parkinson's Disease Case-Control Study: Gut Microbiome Study for Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome profiling
The microbiome profile is analyzed based on stool samples.
Measured: At enrollment
Secondary outcomes (3)
Fecal and serum metabolomics profiling
Metabolomics profiles are analyzed based on blood samples and stool samples.
Measured: At enrollment
Blood and urine proteomics profiling
Proteomics profiles are analyzed based on blood samples and urine samples.
Measured: At enrollment
Brain imaging features
MRI scans are used to extract brain imaging features.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start5 Mar 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Why it stopped: Due to challenges in obtaining faecal samples from patients with Parkinson's disease, a population frequently affected by constipation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848192
- Sponsor's protocol ID
- 20250115ZJS001
- Status last verified
- Aug 2026
- First submitted
- 19 Feb 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Parkinson's Disease Case-Control Study: Gut Microbiome Study for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06848192
- Acronym / sponsor ID
- 20250115ZJS001
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to challenges in obtaining faecal samples from patients with Parkinson's disease, a population frequently affected by constipation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All the participants should be residents living in Hangzhou, China
Key inclusion criteria (8 listed)
- (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.
Key exclusion criteria (23 listed)
- (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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut microbiome profiling
Time frame: At enrollment
The microbiome profile is analyzed based on stool samples.
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Westlake University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome profiling (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.