A Study on Clinical Response Following Eradication Therapy of Helicobacter Pylori Infection in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- 1. H. pylori eradication improves L-dopa 'onset' time and prolongs the L-dopa 'on-time' duration.
研究概览
简要总结
A higher prevalence of Helicobacter pylori infection rate has been demonstrated among PD patients compared to controls. As H. pylori infection is known to interfere with levodopa absorption, we embarked on this is a study to understand the effects of Helicobacter pylori infection eradication among a selected Malaysian population with Parkinsons disease, in relation to levodopa effectiveness and motor improvements.
The study hypotheses are:
- H. pylori eradication improves L-dopa 'onset' time and prolongs the L-dopa 'on-time' duration.
- PD patients with H. pylori infection show clinical improvement in motor disability and quality of life after eradication therapy of H. pylori, assessed using UPDRS-III / PDQ39 questionnaires.
详细描述
Study Background
The earliest observation that there is an association between H. pylori and PD was in 1966 when Strang found that gastric and duodenal ulcers were more common in PD patients than their age and gender-matched controls and that these ulcers preceded the diagnosis of PD by up to 20 years. Upon the discovery of H. pylori and its association with peptic ulcer disease, numerous studies were conducted to look for a correlation between H. pylori and PD.
James Parkinson considered that there may be an association between PD and gastrointestinal pathology when he wrote "Although unable to trace the connection by which a disordered state of the stomach and bowels may induce a morbid action in a part of the medulla spinalis, ...little hesitation needs be employed before we determine on the probability of such occurrence" (pg 64, The Shaking Palsy).
A direct causal relationship was hypothesised by Altschuler who proposed that H. pylori might play a part in the biosynthetic route for MPTP or MPTP-like substance that have a direct neurotoxic effect on the dopaminergic neurons.
In 1999, Charlett et al. observed that cardinal features of PD, namely bradykinesia, rigidity and abnormal posture was significantly more prevalent in siblings of PD patients compared to controls. Positive H. pylori serology was found in 70% of PD patients and 63% of their siblings compared to 36-43% of controls. They concluded that familial transmission of H. pylori might account for the significantly higher prevalence of parkinsonism in siblings of PD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's disease (PD) by a neurologist
- •Age more than 18 years
- •Written informed consent given either by the patient or next of kin
- •Patient on L-DOPA therapy
排除标准
- •Patients with a diagnosis of secondary parkinsonism, and Parkinson's plus syndrome
- •History of recent proton pump inhibitors (PPIs) or Histamine (H2) antagonist use for at least 4 weeks prior to the urea breath test
- •History of recent antibiotics use (less than 6 months)
- •Inability to perform urea breath test
研究组 & 干预措施
Eradication therapy
The patients who were positive for H.pylori infection are entered into an eradication therapy protocol which includes oral esomeprazole 40mg daily, oral clarithromycin 500mg bd and oral amoxicillin 1000mg bd for 14 days.
干预措施: Eradication therapy for H.pylori infection (Drug)
Eradication therapy
The patients who were positive for H.pylori infection are entered into an eradication therapy protocol which includes oral esomeprazole 40mg daily, oral clarithromycin 500mg bd and oral amoxicillin 1000mg bd for 14 days.
干预措施: Eradication of Helcobacter Pylori (Drug)
Eradication therapy
The patients who were positive for H.pylori infection are entered into an eradication therapy protocol which includes oral esomeprazole 40mg daily, oral clarithromycin 500mg bd and oral amoxicillin 1000mg bd for 14 days.
干预措施: Eradication therapy for Helicobacter pylori (Drug)
结局指标
主要结局
1. H. pylori eradication improves L-dopa 'onset' time and prolongs the L-dopa 'on-time' duration.
时间窗: 3months
This was measured by asking the patient to determine the time taken to experience on from the time of ingestion of levodopa and to determine the duration of time that they are ON, while receiving levodopa. The patients are asked to keep a diary if possible. If not, the patients are asked during their visits, baseline visit, visit 1, visit 2 and visit 3
Improvement in L-dopa 'onset' time and L-dopa 'on-time' duration following H.pylori eradication
时间窗: 3 months post eradication
Patients are followed up every 4 weeks, for 12 weeks ( 3 visits). The levodopa onset time is calculated based on the time taken to achieve on following levodopa ingestion, while the ON-time duration is the time the patient remains on following levodopa ingestion. Patients are asked to keep a diary, if possible.
次要结局
- Improvement in motor disability after eradication therapy of H. pylori, assessed using UPDRS-III , and improvement in quality of life using PDQ39(3 months post eradication)
研究者
Dr Norlinah Mohamed Ibrahim
Prof Datin
National University of Malaysia