Helicobacter Pylori Eradication in Parkinson's Disease: A Double-blind Randomised Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- "On-medication" MDS-UPDRS Part III score
研究概览
简要总结
It has been hypothesized, based on epidemiological observations, that Helicobacter pylori (HP) infection may play a role in the pathogenesis of Parkinson's Disease (PD). Previous studies have also shown that HP eradication therapy may result in improvements in levodopa pharmacokinetics and motor fluctuations. This study aims to examine the effects of HP eradication, using a double-blind randomized placebo-controlled trial design in a relatively large cohort of patients. Outcomes of interest include motor function, gastrointestinal symptoms and health-related quality of life. The investigators hypothesize that HP eradication will lead to improvements in motor function. The primary outcome of interest is the "ON"-medication Unified PD Rating Scale (UPDRS) Part III score at 3 months. Secondary outcomes include Purdue Pegboard Score, Timed Test of Gait, Dyskinesia and Bradykinesia scores measured by Parkinson's Kinetigraph (PKG), Leeds Dyspepsia Questionnaire (LDQ), Parkinson's Disease Questionnaire (PDQ-39), UPDRS Part I, Part II and Part IV; and Montreal Cognitive Assessment (MOCA).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years
- •Provision of written informed consent
- •Clinical diagnosis of Parkinson's Disease (PD) assigned by a consultant neurologist
排除标准
- •History of previous gastric or major abdominal/pelvic surgery
- •History of previous eradication therapy for Helicobacter pylori
- •Antibiotic use in the preceding four weeks or use of anti-acid/prokinetics/laxatives in the preceding one week prior to breath test
- •Recent initiation of dopaminergic medications (within the last three months) or recent adjustment of dopaminergic medications (within the last one month)
- •History of functional neurosurgery for PD
- •No concomitant neurologic disease except PD
- •Medical condition that prevents reliable completion of questionnaire
研究组 & 干预措施
Helicobacter pylori eradication therapy
Amoxycillin 1gm twice a day (BD) Clarithromycin 500mg BD Omeprazole 20mg BD
干预措施: Helicobacter pylori eradication therapy (Drug)
Placebo
Maltodextrin
干预措施: Placebo (Drug)
结局指标
主要结局
"On-medication" MDS-UPDRS Part III score
时间窗: at 3 months after randomisation
次要结局
- "On-medication" UPDRS Part III score(at 1 year post randomisation)
- UPDRS Part IV(at 3 months and 1 year post randomisation)
- UPDRS Part II(at 3 months and 1 year post randomisation)
- UPDRS Part I(at 3 months and 1 year post randomisation)
- "On-medication" Pegboard Score(at 3 months and 1 year post randomisation)
- "On-medication" Timed Gait Score(at 3 months and 1 year post randomisation)
- Parkinson's Kinetigraph (PKG) Bradykinesia and Dyskinesia Scores(at 3 months and 1 year post randomisation)
- Montreal Cognitive Assessment Score(at 3 months and 1 year post randomisation)
- Leeds Dyspepsia Questionnaire(at 3 months and 1 year post randomisation)
- Parkinson Disease Questionnaire (PDQ-39)(at 3 months and 1 year post randomisation)