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Gut Microbiome Analysis in de Novo Parkinson's Patients

Gut Microbiome Analysis in de Novo Parkinson's Patients - DUPARM

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50393
Enrollment
480
Registered
2017-08-21
Start date
2017-10-01
Completion date
Unknown
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Taxonomic classification of fecal microbiota composition through high-throughput sequencing and analysis of the 16S ribosomal RNA gene or metagenomic shotgun sequencing. At a later stage the gut microbiota of left over material can be assessed using other -omics methods.

Secondary

MeasureTime frame
Secondary outcome parameters include the presence and extend of (prodromal) PD symptomatology, specific treatment protocols and possible confounders influencing microbiota composition, including clinical-genetic PD subtypes, colon transit time, systemic inflammation and intestinal wall permeability.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)