Treating Bacterial Overgrowth in Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in "Off" Time as Measured by Patient Diary
研究概览
简要总结
This study investigates the effect of treating Small Intestinal Bacterial Overgrowth (SIBO) in patients with Parkinson's Disease (PD). It will test the hypothesis that treating SIBO with the antibiotic rifaximin will improve motor complications in previously SIBO-positive PD patients.
详细描述
Parkinson's Disease (PD) patients with motor fluctuations will be screened for the presence of Small Intestinal Bacterial Overgrowth (SIBO) using two hydrogen breath tests. SIBO-positive individuals will be eligible to enroll, and randomized to receive either rifaximin or placebo. This study includes two treatment regimens (including a placebo control), designed so that all patients will receive the active drug at some point during the trial. Motor outcomes will be followed for 3 or 6 months following enrollment, depending on the treatment arm to which the subject has been assigned. The primary endpoint is to assess the effect of rifaximin treatment to decrease "off" time in SIBO-positive PD patients.
This pilot study will support the design of a larger, randomized controlled trial investigating the effect of SIBO eradication on reducing motor complications in PD patients with motor fluctuations. The current proposal is designed to demonstrate our ability to detect and treat SIBO in PD patients with motor fluctuations, to inform selection of the best SIBO detection method, to determine the optimal timeline for assessing motor endpoints, and to estimate the duration of benefits after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic PD
- •Daily "off" time ≥ 4 hours
- •No changes in levodopa or any other dopaminergic medications expected during the course of the study
- •Will be screened for cognitive ability (Montreal Cognitive Assessment score of ≥ 24) prior to enrollment
- •Will be screened for presence of SIBO prior to enrollment
排除标准
- •Any comorbid non-PD-associated gastrointestinal (e.g., achlorhydria) or systemic diseases that may alter absorption or confound the study results
- •Exposure to proton pump inhibitors, immunosuppressive drugs, medications that affect GI motility (such as prokinetics, anticholinergics, and tricyclic antidepressants), antibiotics or any other drugs that affect the intestinal flora (such as laxatives) within a month prior to enrollment.
- •Prior deep brain stimulation or ablative functional neurosurgery.
- •Prior allergy to rifaximin
- •Women who are pregnant, lactating, or plan to become pregnant.
研究组 & 干预措施
Three-month follow-up
干预措施: Rifaximin (Drug)
Three-month follow-up
干预措施: Placebo (Drug)
Six-month follow-up
干预措施: Rifaximin (Drug)
Six-month follow-up
干预措施: Placebo (Drug)
结局指标
主要结局
Change in "Off" Time as Measured by Patient Diary
时间窗: baseline to 1 month and 3 months; new baseline at 3 months to 4 months and 6 months
OFF time is the time in which levodopa has ceased to be effective and Parkinsonian symptoms reemerge.
Change in "Off" Time as Measured by Wireless Computer Monitoring System
时间窗: 1, 3, and 6 months
This outcome measure was not analyzed due to low subject enrollment as well as poor subject compliance or data quality in some cases.
次要结局
未报告次要终点
研究者
Alberto Espay, MD, MSc
Associate Professor of Neurology
University of Cincinnati