NCT02185092撤回不适用
Probiotic Use in Patients With Prior COPD Exacerbation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- COPD exacerbations
研究概览
简要总结
The purpose of the study is to examine the hypothesis test that probiotics will reduce the frequency of exacerbation in patients with COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to OUMC or VAMC with a COPD exacerbation and pneumonia with underlying COPD will be eligible and screened.
- •Patients seen in VA Chest Medicine clinic, OU Physicians clinic and Pulmonary fellows clinic at PPOB who have had a COPD exacerbation within the last year.
- •Patients over age 18
- •Patients who have a pulmonary function test (PFT) showing COPD within 1 year of enrollment in the study or if the treating physician plans to obtain PFT as part of the patient's care plan.
- •Patients will be considered to have a diagnosis of COPD if they have a FEV1 of less than 80% of predicted and a FVC/FEV1 ratio of less than 0.70 (as defined by GOLD criteria).
排除标准
- •Patients with less than one year of life expectancy from a concomitant diagnosis
- •Any GI motility disorders or previous bowel resection surgery (short gut syndrome)
- •Any patients with decreased immune function or on medication that may decrease immune function (other than low dose steroid or steroid taper).
- •Patients admitted within the last one year with a diagnosis of pancreatitis
- •Patients unable to give consent will not be included in the study.
- •Patients unable to sign consent
- •Patients already on azithromycin daily for COPD exacerbations
- •Patients under department of corrections custody.
结局指标
主要结局
COPD exacerbations
时间窗: 1 year
The primary end point will be the number of COPD exacerbations.
次要结局
- Antibiotic Use(1 year)
研究者
研究点 (2)
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