Determining the Microbiota Composition of the Middle Meatus in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- nasal inflammatory microbiome
研究概览
简要总结
The exact cause of PD remains unknown, but current theories suggest that it results from a combination of hereditary or genetic factors (i.e. family traits ) and exposure to unknown substances in the environment. The purpose of this study is to investigate whether toxins produced by bacteria that live within the nasal canal (nose) and the intestines of people with PD might have a role in causing the disease. The investigators in this study would like to look at the types of bacteria that live in the nasal canals and intestines of PD subjects and compare them with those of subjects who do not have PD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of Parkinson's disease by United Kingdom Parkinson Disease Society Brain Bank criteria will be recruited.
- •Hoehn & Yahr stage 1-3
- •Parkinson's disease symptomatic treatment will be allowed.
- •Subjects with deep brain stimulation are allowed.
排除标准
- •Occupation expected to change intestinal flora pattern (e.g. sanitation worker)
- •Treatment with medications that may induce parkinsonism (metoclopramide, typical, or atypical antipsychotic agents)
- •Treatment within 12 weeks with systemic antibiotics
- •Known diagnosis of inflammatory bowel disease
- •Symptomatic organic GI disease other than hemorrhoids and hiatal hernia or abdominal surgeries for symptomatic GI disease such as bowel resection, diverticular surgery, colostomy, etc (subjects with a history of an appendectomy or cholesytectomy for benign disease more than 5 years prior to presentation are allowed).
- •Symptomatic functional GI disease that significantly impairs intestinal motility such as scleroderma or use of GI motility drugs
- •Acute illness requiring immediate hospitalization
- •Pre-existent organ failure or comorbidities as these may change GI flora:
- •Liver disease (cirrhosis or persistently abnormal AST or ALT that are 2X> normal);
- •Kidney disease (creatinine>2.0 mg/dL);
- •Uncontrolled psychiatric illness;
- •Clinically important lung disease or heart failure;
- •HIV disease;
- •Alcoholism, unreliable drinking history; or consumption of alcohol more than 3 times a week or binge drinking or drinking more than or equal to 3 drinks per occasion;
- •Transplant recipients;
- •Clinically significant dehydration or clinically detectable ascites or peripheral edema or cardiac failure
- •Presence of short bowel syndrome or severe malnutrition with ideal body weight < or = 90% or
- •Estimated survival <1 year and Karnofsky performance status <50%;
- •Use of immunosuppressive medications within 3 months of enrollment
- •Chronic use of diuretics
结局指标
主要结局
nasal inflammatory microbiome
时间窗: 1 year
For microbiome analysis, in silico community functional predictions will be performed using PICRUSt (Phylogenetic Investigation of Communities by Reconstruction of Unobserved States) and significant differences in Kyoto Encyclopedia of Genes and Genomes (KEGG) ortholog (KO) abundances between groups will be identified. "proinflammatory" and "anti-inflammatory" bacteria taxa will be classified and differences in inflammatory metabolite abundance will be compared.
次要结局
未报告次要终点
研究者
Gian Pal
Assistant Professor of Neurological Sciences
Rush University Medical Center