Parkinson's Disease and csgA DNA presence Parkinson's Disease (a brain disorder that causes unintended or uncontrollable movements) and the presence of csgA (a gene in the bacteria present in the digestive tract)
Conditions
Interventions
Not applicable.
Sponsors
Vertero Therapeutics
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Between 18-80 years of age at ICF signing (inclusive)A diagnosis of PD within previous 10 years from the time of ICF signingCurrent or history of GI dysfunction or constipationAll participants must understand and provide written informed consent prior to any study specific proceduresAble to speak, read, and understand study procedures in Dutch sufficiently to allow completion of all study assessments
Exclusion criteria
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 intoleranceRecent 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 investigatorAny known current or past eating disorder if deemed clinically significant by the investigatorUse of systemic antibiotics within 30 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: The prevalence of detectable csgA DNA in fecal samples of participants diagnosed with PD, as measured by quantitative polymerase chain reaction (qPCR) Part B: The intra-individual and inter-individual variability in fecal csgA DNA levels over time, as measured by droplet digital PCR (ddPCR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Contacts
Public ContactP.H.C. Kremer
Centre for Human Drug Research
Outcome results
None listed