RecruitingNCT07175922
Research Into the Expression of the csgA-gene and How it Changes in Patients With Parkinson's Disease
Evaluation of csgA Prevalence, Gene Expression and Week-to-Week Variability in Participants With Parkinson's Disease and a History of Gastrointestinal Dysfunction
Sponsor
Vertero Therapeutics
Enrollment
200 participants
Start Date
Sep 25, 2025
Study Type
OBSERVATIONAL
Conditions
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 therapies targeting the gut in Parkinson's Disease.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria5
- Between 18-80 years of age at ICF signing (inclusive)
- A diagnosis of PD within 10 years from the time of ICF signing
- Current or history of gastrointestinal (GI) dysfunction or constipation 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 Criteria5
- 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
- Any known current or past eating disorder if deemed clinically significant by the investigator
- Use of systemic antibiotics within 6 months prior to enrollment
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07175922
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