Evaluating the connection between gut bacteria and Parkinson's disease
A Proof-of-concept Study Evaluating the Microbiota-gut-brain Axis
This study is trying to see if the bacteria in the gut affect how Parkinson's disease develops by looking at imaging results from people with Parkinson's and healthy participants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Douliu) |
| Trial ID | NCT06197698 on ClinicalTrials.gov |
What this trial studies
This study investigates the microbiota-gut-brain axis and its potential role in Parkinson's disease by examining how gut bacteria may influence physiological processes related to the disease. It involves 80 patients with Parkinson's disease and 20 control participants, focusing on the uptake of fluorine-18 deoxyglucose (F18-FDG) and technetium-99m TRODAT-1 in imaging studies. The research aims to understand the relationship between gut microbiota composition and the pathogenesis of Parkinson's disease, particularly in relation to intestinal permeability and FDG uptake. Participants will undergo specific imaging techniques to assess these interactions.
Who should consider this trial
Good fit: Ideal candidates include individuals over 20 years old diagnosed with Parkinson's disease and those without the disease for comparison.
Not a fit: Patients currently using Metformin, those who have taken antibiotics in the last three months, or individuals with significant intestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into the treatment and management of Parkinson's disease through modulation of gut microbiota.
How similar studies have performed: While the concept of the microbiota-gut-brain axis is established, this specific approach using imaging techniques in Parkinson's disease is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 80 Parkinson's disease patients over 20 years old (the Unified Parkinson's Disease Rating Scale and Hoehn-Yahr Grading Scale are required to provide clinical staging). 2. 20 non-Parkinson's disease patients over 20 years old (control group). 3. Those who are not currently using Metformin, can tolerate fasting for 8 hours, have not used antibiotics within 3 months, and have no obvious intestinal diseases. 4. Subjects and their families agree to join the trial and agree to undergo fluorine-18 deoxyglucose positron imaging (100 subjects will be paid for by research funds) and phosphonium-99m dopamine transporter scan (20 non-Parkinson's patients will be paid for by research funds) syndrome patients) examination. Exclusion Criteria: 1. Unable to accept positron or single photon angiography such as checking for panic disorder and hemodynamic instability. 2. The possible cancer risk caused by the radiation dose obtained from the experiment cannot be accepted. 3. Pregnant women or women currently breastfeeding. 4. There is a lack of recent unified Parkinson's disease rating scale and Hoehn-Yahr grading scale, making it impossible to know the clinical stage. 5. Those who are currently using Metformin, cannot tolerate fasting for 8 hours, have used antibiotics within 3 months, and have obvious intestinal diseases. 6. The subjects and their families do not agree to join the trial.
Where this trial is running
Douliu
- National Taiwan University Hospital Yunlin branch — Douliu, Taiwan (Recruiting)
Study contacts
- Study coordinator: Yi-Hsien Chou, MD
- Email: iquanchou@gmail.com
- Phone: +886-5-5323911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.