Lung Microbiota in Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- infection
研究概览
简要总结
Role of immunonutrition in modulating the lung microbiota of intubated TBJ patients and how this interaction may affect the infections and outcomes.
For these reasons, the aims of our study are the evaluation of the impact of immunonutrition on the lung microbiota and the relationship between lung microbiota and infection in TBJ patients in ICU.
详细描述
Traumatic brain injury patients, requiring mechanical ventilation admitted to ICU will be randomly divide in two groups receiving standard nutrition or specialized formula.
Lower lavage (Bronco Alveolar Lavage: BAL) samples will be collected at admission in ICU and at day 7 for the microbiota analysis. Clinical follow-up at day 28 will be obtained
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
specialized nutrition and microbiota analysis
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults (age > 18 years),
- •paziente with traumatic brain injury
排除标准
- •pregnant women,
- •patients with gastric content inhalation
- •patients with chronic inflammatory bowel diseases
- •patients underwent major abdominal surgery and/or organs/tissues transplant
- •patients on corticosteroid and/or immunosuppressive therapy
研究组 & 干预措施
microbiota and specialized nutrition
microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patietns treated with specialized nutrition
干预措施: specialized nutrition (Dietary Supplement)
microbiota and standard nutrition
microbiota analysis in lower lavage (Bronco Alveolar Lavage: BAL) samples in patients treated with standard nutrition
干预措施: standard enteral nutrition (Dietary Supplement)
结局指标
主要结局
infection
时间窗: pulmonary infection within 28 days
pulmonary infection in mechanically ventilated patients
次要结局
未报告次要终点
研究者
Cotoia Antonella
Principal Investigator
University of Foggia