DRKS00027061
Completed
Phase 2
Analysis of changes in the gut microbiome, and dosing of dopaminergic therapy under supplementation of short-chain fatty acids and prebiotics as dietary supplements in the context of PD - PRE-PD Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- G20
- Sponsor
- BASF SE
- Enrollment
- 80
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. age at PD: 18\-90 years
- •2\. primary Parkinson's syndrome
- •3\. moderate disease severity (stable daily levodopa dose 500\-850 mg daily)
- •4\. full orientation to time, place and person
- •5\. sufficient knowledge of German (able to give informed consent)
- •6\. independent mobility without, with unilateral or bilateral walking assistance
Exclusion Criteria
- •1\. poor general condition
- •2\. pregnancy
- •3\. severe concomitant disease or organ dysfunction (heart failure, NYHA stages III\-IV, severe respiratory failure (e.g., with resting dyspnea), irreversible multiorgan failure, sepsis, acute viral hepatitis)
- •4\. serious previous diseases of the gastrointestinal tract
- •5\. malignancy (current or history with current follow\-up/treatment)
- •6\. illness or medical treatment incompatible with study participation (pending surgical procedure, etc.)
- •7\. immunosuppressive therapy in the last 6 months (e.g. mitoxantrone, azathioprine, cyclophosphamide, MTX)
- •8\. intake of antibiotics or metformin during the past 3 months
- •9\. vegan dietary habits
Outcomes
Primary Outcomes
Not specified
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