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临床试验/DRKS00027061
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

BASF SE0 个研究点目标入组 80 人开始时间: 2021年11月19日最近更新:
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

发起方
BASF SE

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