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临床试验/NCT03575195
NCT03575195暂停1 期

Microbiota Intervention to Change the Response of Parkinson's Disease

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2019年7月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
暂停
入组人数
86
试验地点
1
主要终点
Percent of OFF time according to home motor diaries

研究概览

简要总结

The clinical phenotype of Parkinson's disease (PD) is quite variable, as is the response to and side effects from medications. While many patients respond to carbidopa/levodopa early on, motor fluctuations and dyskinesias can become a problem as the condition progresses, causing significant impairment in function and quality of life. The gut microbiome is of increasing interest in PD, potentially contributing to pathophysiology and clinical phenotype. Furthermore, gut bacteria are capable of metabolizing levodopa, which may decrease its ability to reach the central nervous system and could explain the variable effect seen clinically. Altering the population of drug-metabolizing bacteria could improve the clinical symptoms of PD and the benefit seen with medications. The investigators hypothesize that the gut microbiome in people with PD correlates with their phenotypic characteristics, which can be improved with targeting the microbiome through dietary or therapeutic interventions. The investigators propose a two-part clinical trial. First, a cross-sectional analysis will correlate the microbiome profile with (a) the clinical phenotype of PD and (b) medication response. Second, a randomized, controlled trial, will evaluate the effect of microbiome manipulation on clinical phenotype and medication response. The investigators plan to reduce the level of bacteria through antibiotic use, resetting the potentially disadvantageous microbiome population. Outcomes will include changes in clinical symptoms, alterations in the the microbiome, and changes in serum markers of inflammation. This thorough characterization will broaden our understanding of the gut-brain axis significantly in PD in clinically relevant ways that have yet to be explored.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parkinson's disease
  • Stable on levodopa therapy with fluctuations

排除标准

  • Chronic gastrointestinal disease
  • Recent antibiotic or probiotic therapy
  • Immunocompromised

研究组 & 干预措施

Intervention

Experimental

Rifaximin

干预措施: Rifaximin (Drug)

Placebo

Placebo Comparator

Matching placebo

干预措施: Placebo (Other)

结局指标

主要结局

Percent of OFF time according to home motor diaries

时间窗: Two weeks

Patients with Parkinson's disease often have times where levodopa is providing therapeutic benefit and times when it is not. "OFF" time indicates the times of day where levodopa therapy is not providing therapeutic benefit. An outcome of the trial will be the change in medication OFF time that the participant experiences at home, according to motor diaries.

MDS-UPDRS Part III

时间窗: Two weeks

The Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a validated scale that quantifies many of the symptoms and signs of Parkinson's disease. Part III in particular focuses on the motor symptoms of Parkinson's disease through a neurologic exam. The exam is often performed when medications are held for 8-12 hours (the "OFF" state) and again when medications are given and providing therapeutic benefit (the "ON" state), and the difference between scores is calculated. The scale goes from a minimum of 0 to a maximum of 132. There is no specific cutoff, but a higher score indicates a higher severity of symptoms. The trial will examine the change in the MDS-UPDRS Part III both OFF and ON medication after the intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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