Constipation and Changes in the Gut Flora in Parkinson's Disease: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Micro-organism prevalence in stool sample
研究概览
简要总结
The aim of this study is to investigate the link between gut health and Parkinson's disease
详细描述
Parkinson's disease (PD) is a common, age-related neurological condition, affecting approximately 145,000 people in the United Kingdom. Diagnostic symptoms include stiffness, tremor, unsteadiness and slow movements. Interestingly, while PD is usually considered to be a neurological condition, pathological changes occur in the gut years before diagnosis, often causing constipation. As such, the gut has attracted attention as a possible therapeutic target.
Previous studies have shown different profiles of gut bacteria and the short chain fatty acids (SCFAs) they produce in people with PD. There is evidence these changes might be significant to the disease course, as faecal transplants from people with PD worsened symptoms in a mouse model of PD. The mechanism for this is unclear, but changes in SCFAs and gut wall inflammation, have both been suggested. Studies so far have compared gut bacteria in people with and without PD, however, as the healthy controls often don't have constipation, it is unclear if the differences seen are due to PD itself or the associated constipation.
This pilot study aims to determine differences in the frequency of gut micro-organisms (bacteria, fungi and archaea) and gut function, other than those caused by constipation. 40 participants with a new diagnosis of PD will be recruited from Movement Disorder clinics within National Health Service (NHS) Grampian. 40 healthy (non-PD) controls will be recruited from the PD participants households (whenever feasible). All 80 participants will be clinically assessed and asked to provide two stool samples. The samples will be analysed for the frequency of gut micro-organisms, changes in gut function (short chain fatty acid concentrations) and gut inflammation (calprotectin concentrations).
The aim of this pilot study is to determine the key differences in gut micro-organisms in PD compared to controls, which may have a role in disease progression. It is likely that the results of this proof of concept study would need to be confirmed in a larger study before the investigators are able to plan an intervention trial, such as testing a prebiotic product, with the aim of normalising gut micro-organisms, and potentially modifying the disease course.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with Parkinson's disease
- •Community-dwelling patients with newly diagnosed PD who have not yet started medication for Parkinson's disease.
- •Control Participants
- •1. Healthy (non-Parkinsonian) members of the participants household will be invited to act as controls.
排除标准
- •Use of oral or intravenous antibiotics in the last 8 weeks.
- •Active gastrointestinal disease, not including constipation or irritable bowel syndrome without other symptoms.
- •Current use of medications which cause/worsen constipation e.g., opioids, tramadol, gabapentin, pregabalin.
- •Potential controls will be excluded if they report prodromal symptoms of PD, such as anosmia or rapid eye movement (REM) sleep disorder or display parkinsonian signs on examination.
- •Inability to give informed consent at any stage of the study e.g., because of dementia.
研究组 & 干预措施
Parkinson disease
Participants with newly diagnosed Parkinson's disease
Control Subjects
Control subjects - will be selected from household/spousal contacts of the participants with Parkinson's disease
结局指标
主要结局
Micro-organism prevalence in stool sample
时间窗: Within two months of baseline
Stool samples will be posted to the Rowett Institute, and processed and analysed in the laboratory at The Rowett Institute, University of Aberdeen. The samples will be analysed for water content and microbial RNA/DNA will be extracted for genome analysis. When the analysis is complete, the faecal samples will be destroyed.
Micro-organism prevalence in stool sample
时间窗: Baseline
Stool samples will be posted to the Rowett Institute, and processed and analysed in the laboratory at The Rowett Institute, University of Aberdeen. The samples will be analysed for water content and microbial RNA/DNA will be extracted for genome analysis. When the analysis is complete, the faecal samples will be destroyed.
次要结局
- Analysis of stool samples for concentration of short chain fatty acids(Baseline)
- Analysis of stool samples for concentration of calprotectin(Baseline)
- To assess the reliability of bio-impedence analysis in determining fat mass in older adults with and without PD(Baseline)
- To assess the reliability of bio-impedence analysis in determining fat mass in older adults(Four weeks after the baseline assessment)
- Analysis of stool samples for markers of gut function (short chain fatty acids and calprotectin)(Within two months of the baseline sample)
- To assess the extent of swallowing problems (dysphagia) by a questionnaire(Baseline)
- To assess taste sensation using a simple test(Baseline)
- To assess dietary intake over a 24 hour period using a structured interview(Baseline)
- To assess the extent of swallowing problems using a standardized swallowing test(Four weeks after the baseline assessment)
- To assess the reliability of bio-impedence analysis in determining fat mass in older adults(Four weeks after baseline assessment)
- To assess the extent of swallowing problems using a standardized swallowing test(Baseline)
- To assess the reliability of bio-impedence analysis in determining fat mass in older adults(Baseline)