About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with a diagnosis of Parkinson's disease within the last 10 years in the Netherlands
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
csgA DNA
Part A: The prevalence of detectable csgA DNA in stool samples from participants diagnosed with Parkinson's disease, as measured by polymerase chain reaction (PCR).
csgA DNA
Part B: The intra-individual and inter-individual variability in stool csgA DNA expression, measured over time, as measured by PCR.
Sponsors and contacts
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