Weight Loss in Parkinson's Disease and the Potential Role of Small Bowel Bacterial Overgrowth
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO)
研究概览
简要总结
The potential role of small bowel bacterial overgrowth (SBBO) in weight loss occurring in patients with Parkinson's Disease (PD) has not previously been examined. Our hypothesis was that SBBO is an important contributor to the development of weight loss in individuals with PD. The investigators proposed to 1) examine the role of SBBO in weight loss occurring in patients with PD and 2) determine the response to its treatment with a poorly absorbed antibiotic. The investigators performed a prospective, observational case-control study (Part 1) with an open-label therapeutic component (Part 2). Cases were defined as those PD patients who experienced significant weight loss while Controls were defined as those PD patients who did not experience significant weight loss.
详细描述
Part 1:
Consecutive patients seen in the Parkinson's disease clinic at Mayo Clinic in Arizona were approached to participate. After the determination of their eligibility and appropriate signed informed consent, all PD patients (i.e., both Case and Control groups) underwent the following:
- Assessment of demographic features, weight history and PD history
- PD and other medications
- Determination of PD severity using the Unified Parkinson's Disease rating scale
- Gastrointestinal Symptom Severity Index (GISSI) and modified GISSI.
- Determination of usual calorie and nutrient intake (Brief Block Food Frequency Questionnaire)
- Paffenbarger physical activity questionnaire
- Quality of life (SF12 and PD-specific)
- Hospital Anxiety and Depression Scale
- Glucose hydrogen breath test (SBBO test)
- Qualitative assessments of smell and taste
All questionnaires were completed during the 2 hour breath test.
Part 2:
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
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- •Wheelchair-bound, akinetic individuals
- •Tube-fed individuals
- •Presence of dementia
- •Unwilling or unable to complete the tests
- •Allergic or intolerant to rifaximin
- •Presence of chronic upper or lower gastrointestinal disorders that have symptoms that may be confused with SBBO (e.g., irritable bowel syndrome, inflammatory bowel disease, celiac disease, functional dyspepsia, gastroparesis, and chronic pancreatitis)
- •Presence of prior surgery on the gastrointestinal tract except cholecystectomy, appendectomy or herniorrhaphy
- •Presence of severe concomitant acute or chronic medical condition that may interfere with the completion or interpretation of the test results
- •Women of childbearing potential. Given the age of patients with Parkinson's disease, we do not anticipate this being a large population.
- •Use of antibiotics within 1 month of breath testing
研究组 & 干预措施
Case Group
All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO twice a day (BID) for 14 days. Subjects in the case group were in the study for 3 months.
干预措施: Rifaximin (Drug)
结局指标
主要结局
Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO)
时间窗: Baseline to 2 hours
SBBO is measured by the Hydrogen Breath Test, which measures the hydrogen and methane gas produced by bacteria in the small bowel that has diffused into the blood, then lungs for expiration. After an overnight fast, subjects ingested a solution consisting of 50 grams of glucose mixed in 150 mL of water. Immediately before ingestion of glucose and at 20-minute intervals for 2 hours following ingestion, laboratory staff collected end-expiratory breath samples and analyzed them for hydrogen and methane using a Quintron sample correction (SC) breath microlyzer. A diagnosis of SBBO was defined by an increase in expiration of 12 parts per million (ppm) or more of hydrogen and/or methane.
次要结局
- Weight Change in Case Group After Treatment(baseline, 3 months)
- Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group(baseline, 3 months)
- Paffenbarger Physical Activity Questionnaire (PPAQ)(Baseline)
- PD-specific Quality of Life Questionnaire (PDQ-39)(baseline)
- Gastrointestinal Symptom Severity Index (GISSI)(Baseline)
- PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group(Baseline and 3 months)
- Hospital Anxiety and Depression Scale (HADS)(Baseline)