From the Brain to the Bugs: Evolution of Oropharyngeal and Rectal Microbiota of Patients With Severe Traumatic Brain Injury Admitted in ICU
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in microbiota alpha-diversity as measured by Shannon index
研究概览
简要总结
Modifications of the human gut microbiota have been associated with different pathological conditions such as obesity, inflammatory bowel diseases and neurodegenerative diseases. Recently the " Brain-Gut Axis ", a bidirectional communication axis between brain and gut, has been described. In recent animal studies, an acute brain injury was associated with rapid modifications of the gut microbiota.
In humans, traumatic brain injury (TBI) is a leading cause of death and disability. The patterns of gut and oropharyngeal microbiota following TBI are unknown. The primary purpose of this study is to characterize gut and oropharyngeal microbiota of patients with severe TBI.
详细描述
Study Protocol :
Observational prospective cohort study.
Patients
Patients admitted to the ICU for severe trauma will be included. Two groups of patients with severe trauma will be studied:
- Patients with isolated severe traumatic brain injury (TBI): TBI with initial Glasgow Coma Scale (GCS) ≤ 8 and AISextrahead score ≤3
- Patients with severe trauma without TBI (AISextrahead score > 3)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Admission to Bicêtre Hospital Trauma Center for severe trauma with:
- •either isolated severe traumatic brain injury (TBI): TBI with initial Glasgow Coma Scale (GCS) ≤ 8 and AISextrahead score ≤3; either severe trauma without TBI (AISextrahead score > 3)
- •Estimated ICU length of stay 48 hours or more
排除标准
- •Antimicrobial therapy within the previous 3 months
- •Long-term corticosteroids use
- •Active cancer
- •Institutionalized patient
- •Gastro-intestinal perforation or emergency gastro-intestinal surgery following trauma
- •Withdrawal of consent
- •Patient under guardianship
- •Pregnant or breastfeeding women
结局指标
主要结局
Change in microbiota alpha-diversity as measured by Shannon index
时间窗: From day 0 to day 90
The oropharyngeal and rectal swabs, performed at day 0, day 2, day 7 after ICU admission and weekly thereafter until ICU discharge or no later than day 90, will be used for DNA extraction and the bacterial 16S rRNA amplification and sequencing in order to identify the bacterial species colonizing the gut.
次要结局
- Number of patients acquiring colonization or infection with multidrug resistant bacteria during ICU stay(From day 0 to day 90)
- Alpha and beta-diversities of oropharyngeal and rectal microbiota at different times post trauma.(From day 0 to day 90)
- ICU-acquired infections(From day 0 to day 90)
- Death at ICU discharge and 90 days post trauma.(From day 0 to day 90)
- Disability Rating Scale (DRS-F) score at 90 days post trauma(From day 0 to day 90)