Research Into the Expression of the csgA-gene and How it Changes in Patients With Parkinson's Disease
Recruiting · NCT07175922 · Observational (researchers observe without assigning treatment) · Lead sponsor: Vertero Therapeutics
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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 30 days prior to enrollment
Where it is running
1 location listed.
- Center for Human Drug Research - Leiden, Netherlands