High Fiber in Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- changes in microbiome composition
研究概览
简要总结
The purpose of the research is to determine the effects of a high-fiber nutritional supplement (HFS) on the bacteria, viruses, and fungi that live in different regions of the body in those with Parkinson's disease (PD). We will compare the bacteria, viruses, and fungi of those with PD to those without PD (healthy controls). We will also examine the effects of transplanting stool from humans into laboratory mice with or without Parkinson-like pathology to understand how the microbiome influences the brains of animals. We can use this information to get a better understanding of how changing the microbiome might help humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parkinson's disease patients who are untreated
排除标准
- •Occupation expected to change the microbiome (e.g. sanitation worker)
- •Treatment with medications that may induce parkinsonism (e.g. metoclopramide, typical or atypical antipsychotic agents)
- •Treatment within 12 weeks with oral or intravenous antibiotics
- •Known diagnosis of inflammatory bowel disease
- •Symptomatic organic gastrointestinal (GI) disease (other than hemorrhoids and hiatal hernia) or abdominal surgeries for symptomatic gastrointestinal disease such as bowel resection, diverticular surgery, colostomy; subjects with a history of an appendectomy or gallbladder removal for non-cancerous 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 conditions as below:
- •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;
- •Diabetes;
- •BMI > 30
- •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%
- •Use of immunosuppressive medications in 3 months prior to enrollment
- •Anti-inflammatory medication use within 3 weeks of enrollment.
- •Chronic use of diuretics
研究组 & 干预措施
Parkinson's patients
Parkinson's patients who will receive a high fiber supplement
干预措施: High Fiber supplement (Drug)
结局指标
主要结局
changes in microbiome composition
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
Gian Dev Pal, MD, MS
Assistant Professor
Rutgers, The State University of New Jersey