Gut Microbiome Analysis in de Novo Parkinson's Patients
- Conditions
- 10028037Parkinson's Disease
- Registration Number
- NL-OMON50393
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 480
All participants:
- Written informed consent
Study group:
- Diagnosed Parkinson*s disease according to the UK Parkinson*s Disease Society
Brain Bank Criteria
Control group:
- Healthy sex- and age-matched controls, also matched according to presence and
severity of constipation.
All participants:
Gastrointestinal exclusion criteria:
- Active or persistent primary disease of the gastrointestinal tract
- History of peritonitis, severe endometriosis, abdominal, intestinal or
urogenital fistula,
- Hepatobiliar or pancreatic disease (except asymptomatic cholecystolithiasis)
- History of abdominal or anorectal surgery, except minor surgery such as
uncomplicated appendectomy or cholecystectomy (>6 months ago)
- Severe gynaecological prolapse (grade III)
- Cancer and/or adjuvant treatment within the last 6 months
- Within the last three months: narcosis, analgosedation, endoscopic procedure
of the gastrointestinal tract, abdominal trauma
- Within the last three months: gastrointestinal tract infection, food
intoxication,
Study group:
- History of dopaminergic medication use
Control group:
- History of neurodegenerative disease, in particular signs of parkinsonism.
- Probable prodromal PD. Controls will, however, be matched according to
presence and severity of constipation as a possible confounder.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Taxonomic classification of fecal microbiota composition through<br /><br>high-throughput sequencing and analysis of the 16S ribosomal RNA gene or<br /><br>metagenomic shotgun sequencing. At a later stage the gut microbiota of left<br /><br>over material can be assessed using other -omics methods.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome parameters include the presence and extend of (prodromal) PD<br />symptomatology, specific treatment protocols and possible confounders<br />influencing microbiota composition, including clinical-genetic PD subtypes,<br />colon transit time, systemic inflammation and intestinal wall permeability.</p>