DRKS00027061已完成2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- BASF SE
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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