Investigating gut fungi differences in Parkinson's disease

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

This study is looking at the differences in gut fungi between healthy people and those with Parkinson's disease to see how it might relate to brain health and function.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 50 Years to 75 Years
• Sex: All
• Sponsor: Westlake University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06848192 on ClinicalTrials.gov

What this trial studies

This observational study focuses on healthy volunteers and patients with Parkinson's disease aged 50-75 years in Hangzhou, China. It aims to systematically investigate the differences in intestinal fungi between these two groups and explore the molecular mechanisms of Parkinson's disease using multi-omics data. The study will collect demographic information, clinical characteristics, biological samples, and brain MRI data to understand the association between gut fungi and brain structure and function through the gut-brain axis.

Who should consider this trial

Good fit: Ideal candidates include men and women aged 50 to 75 years with a clinical diagnosis of Parkinson's disease.

Not a fit: Patients with atypical or secondary parkinsonism or clinically diagnosed dementia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the role of gut fungi in Parkinson's disease, potentially leading to new therapeutic strategies.

How similar studies have performed: While studies have explored gut microbiota in relation to neurodegenerative diseases, the specific focus on gut fungi in Parkinson's disease is relatively novel.

Eligibility criteria

Inclusion Criteria:

(For PD patients)

1. Men or women aged 50 to 75 years.
2. Clinical diagnosis of Parkinson's disease (based on MDS Parkinson's disease diagnostic criteria)
3. 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.
4. Able to provide informed consent.

(For healthy volunteers)

1. Age (±2 years) and sex-matched healthy control individuals for each Parkinson's disease patient.
2. Able to provide informed consent.

Exclusion Criteria:

(For PD patients)

1. 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).
2. The presence of clinically diagnosed dementia as determined by the investigator.
3. Previous MRI scans showed clinically significant neurological disorders (as judged by the investigator).
4. Serious illness (e.g., heart failure or malignancy).
5. Smoking more than 15 cigarettes a day and a history of alcohol or drug addiction
6. Inflammatory gastrointestinal diseases.
7. Chronic diseases that may affect the gut microorganism (e.g., diabetes, cirrhosis, or cardiovascular disease).
8. Blood or autoimmune disease, or use of immunosuppressants in the past 3 months.
9. Antibiotics have been used within 3 months prior to sample collection.
10. Chronic constipation.

(For healthy volunteers)

1. Have a first-degree relative with Parkinson's disease (e.g. biological parent, sibling, or child).
2. Current or past clinically significant neurological disorders (as judged by the investigator).
3. Previous MRI scans showed clinically significant neurological disorders (as judged by the investigator).
4. Use of the following drugs in the 6 months prior to the screening visit: dopamine blockers (antipsychotics), metoclopramide, and riserpine.
5. Inflammatory gastrointestinal diseases.
6. Smoking more than 15 cigarettes a day and a history of alcohol or drug addiction
7. Chronic diseases that may affect the gut microorganism (e.g., diabetes, cirrhosis, or cardiovascular disease).
8. Blood or autoimmune disease, or use of immunosuppressants in the past 3 months.
9. Antibiotics have been used within 3 months prior to sample collection.
10. Chronic constipation.
11. Participating in other clinical trials

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Ju-Sheng Zheng, PhD

Conditions Parkinson Disease