NCT05416814已完成早期 1 期
Safety and Feasibility of Kefir Administration in Critically Ill Adults
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and feasibility of kefir administration in critically ill adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Critically ill adult patients receiving antibiotics.
- •Functional GI tract (able to tolerate oral diet or tube feeding).
排除标准
- •Received antibiotics for >72 hours prior to enrollment.
- •Known immunosuppression (due to medications including chronic steroids, TNF-alpha inhibitors, monoclonal antibodies, immunosuppressive antimetabolites, etc.).
- •Compromised gut integrity (bowel resection, GI malignancy, GI bleed, inflammatory bowel disease).
- •History of CDI within 60 days.
- •Liver failure or pancreatitis.
- •Dairy intolerance or milk allergy.
- •Patients consuming probiotics at baseline.
- •Artificial heart valve.
- •Extremely poor prognosis and not expected to survive the treatment period.
结局指标
主要结局
Adverse Events
时间窗: 30 days
Number of adverse effects related to kefir administration including vomiting, aspiration, diarrhea, interactions with medications or tube feeds, bacteremia secondary to a bacterium in kefir
Feasibility of Kefir administration
时间窗: 30 days
Number of subjects to have more than 75% of doses given when subject is allowed to have PO/feeding tube administration and are tolerated
次要结局
未报告次要终点
研究者
Lioudmila Karnatovskaia
Principal Investigator
Mayo Clinic
研究点 (2)
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