Examining gut microbiota's role in early Parkinson's disease progression
Gut Microbiota in the Progression of Alpha-synucleinopathies: a Prospective Follow-up Study
Chinese University of Hong Kong · NCT05353868
This study is looking at how the bacteria in the gut might affect the early progression of Parkinson's disease in people who have a sleep disorder that often leads to the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 490 (estimated) |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05353868 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between gut microbiota characteristics and the progression of neurodegeneration in patients with early Parkinson's disease, particularly those exhibiting idiopathic REM sleep behavior disorder (iRBD). By analyzing the gut microbiome of these patients, the study seeks to identify potential early markers of neurodegenerative disease progression. The research leverages the unique opportunity presented by iRBD, which has a high likelihood of converting to Parkinson's disease, to explore the gut-brain connection and its implications for early intervention. No interventions will be administered, as the focus is on observational data collection.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with early Parkinson's disease who exhibit symptoms of idiopathic REM sleep behavior disorder.
Not a fit: Patients with pre-existing gastrointestinal diseases or those who have used probiotics or antibiotics within three months prior to sample collection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early identification of neurodegenerative disease progression and inform preventive strategies for patients at risk.
How similar studies have performed: While the gut-brain axis is a growing area of research, this specific approach focusing on gut microbiota in the context of iRBD and early Parkinson's disease is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * recruit from the subjects who completed the baseline study Exclusion Criteria: * The use of probiotics or antibiotics within three months prior to sample collection; * Pre-existing gastrointestinal diseases, such as inflammatory bowel disease. * Not capable of giving informed consent for participation of the study.
Where this trial is running
Hong Kong
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (RECRUITING)
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.
Conditions: REM Sleep Behavior Disorder, Gut microbiota, Parkinson's disease, REM sleep behavior disorder