Actively Recruiting
Evaluation of csgA Prevalence, Gene Expression, and Week-to-Week Variability in People With Parkinson's Disease and Gastrointestinal Dysfunction
Led by Vertero Therapeutics · Updated on 2026-02-19
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring how often and how much the csgA gene, found in certain gut bacteria, appears and varies in people with Parkinson's Disease (PD). This study aims to understand differences in the gut microbiome related to PD, especially given the disease's two main progression patterns: brain-first and body-first. The body-first type involves the gut and related nerves, potentially influenced by bacterial proteins like csgA that may trigger disease processes. The study focuses on measuring the presence and week-to-week changes of the csgA gene in stool samples from participants diagnosed with PD who also have a history of gastrointestinal issues. Participants will provide baseline and weekly stool samples over four weeks to assess gene expression and variability. These measures help researchers understand the role of gut bacteria in PD and support future development of microbiome-targeted therapies. Participants will be involved for a short period during which they provide stool samples and complete assessments related to their gastrointestinal health and PD diagnosis. The primary outcomes include detecting csgA DNA in baseline and weekly stool samples. This observational study does not involve treatment but collects important data on gut bacteria's relationship to PD progression, monitored closely by the research team over the study duration.
CONDITIONS
Brief Title
Research Into the Expression of the csgA-gene and How it Changes in Patients With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 80 years old at the time of consent
- Diagnosed with Parkinson's Disease within the last 10 years
- Current or past gastrointestinal problems or constipation
- Able to understand and provide written informed consent
- Able to speak, read, and understand Dutch well enough to complete study assessments
You will not qualify if you...
- Significant gastrointestinal disorders such as Crohn's disease, ulcerative colitis, celiac disease, irritable bowel syndrome, or lactose intolerance
- Recent gastrointestinal infection within the past 3 months
- Major gastrointestinal surgery, excluding appendectomy or cholecystectomy
- Current or past eating disorders deemed significant
- Use of systemic antibiotics within 6 months before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants provide stool samples to assess the prevalence and week-to-week variability of the csgA gene in their gut microbiome.
Weekly visits for stool sample collection over 4 weeks
Duration - Up to study completion
Participants are observed for changes in microbiome markers related to Parkinson's Disease over time.
1 final visit (in-person) for study completion assessments
Trial Site Locations
Total: 1 location
1
Center for Human Drug Research
Leiden, Netherlands
Actively Recruiting
Research Team
P
P.H.C. Kremer
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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