Status:
RECRUITING
Research Into the Expression of the csgA-gene and How it Changes in Patients With Parkinson's Disease
Lead Sponsor:
Vertero Therapeutics
Conditions:
Parkinsons Disease (PD)
Eligibility:
All Genders
18-80 years
Brief Summary
This study seeks to understand the prevalence and variability of a gut bacteria gene called csgA in people with Parkinson's Disease. This understanding could inform development of potential new therap...
Detailed Description
Parkinson's Disease (PD) is a neurodegenerative disorder traditionally associated with motor and non-motor symptoms due to the loss of dopaminergic neurons in the nervous system. Recent research highl...
Eligibility Criteria
Inclusion
- A diagnosis of PD within 10 years from the time of ICF signing
- A history of gastrointestinal (GI) dysfunction or constipation prior to PD diagnosis at the discretion of the investigator based on screening assessment
- All participants must understand and provide written informed consent prior to any study specific procedures
- Able to speak, read, and understand study procedures in Dutch sufficiently to allow completion of all study assessments
Exclusion
- Any known GI disorder if deemed clinically significant by the investigator. GI disorders may include, but are not limited to: Crohn's disease, ulcerative colitis, celiac disease, irritable bowel syndrome, or lactose intolerance
- Recent GI infection in the past 3 months if deemed clinically significant by the investigator.
- Major GI surgery (excluding appendectomy/cholecystectomy), such as bariatric surgery, gastrectomy, esophagectomy, vagotomy, small intestine surgeries, any type of colectomy, colostomy and anorectal surgeries if deemed clinically significant by the investigator
Key Trial Info
Start Date :
September 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07175922
Start Date
September 25 2025
End Date
December 31 2025
Last Update
November 18 2025
Active Locations (1)
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1
Center for Human Drug Research
Leiden, Netherlands