G20.0 G20.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Early idiopathic PD patients (age < 75 yrs, diagnosis before 2010), with mild constipation, without relevant gastro-intestinaldiseases, without motor-fluktuations or healthy spouses
Exclusion criteria
Exclusion criteria: - Levodopa pump therapy, apomorphine pump therapy, deep brain stimulation (DBS) - Ongoing antibiotic therapy - Immunosuppressive or cytostatic therapy in the last 3 months before starting the diet - Vegan lifestyle (except vegetarian lifestyle) - Clinically significant hepato-biliary disease (liver cirrhosis, pancreatitis, tumors) - Major gastrointestinal surgery in the last 5 years (except: cholecystectomy and appendectomy) - Uncontrolled or chronic gastrointestinal disease (chronic inflammatory bowel disease: ulcerative colitis, Crohn's disease, infectious gastroenteritis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i) modification of SCFA in faeces (concentration in faeces), ii) changes in gut microbial composition (next generation sequencing, relative abundance), and iii) changes in bacterial metabolism based on bacterial genomes (next generation sequencing, relative abundance) and metabolomics analysis in urine and faeces (NMR metabolomics). | — |
Secondary
| Measure | Time frame |
|---|---|
| i) changes in motor symptoms (UPDRSIII), ii) modification of gastro-intestinal symptoms (modified GSRS, stool frequency, side effects). | — |
Countries
Germany
Contacts
Universitätsklinikum Bonn, Neurologie