跳至主要内容
临床试验/NCT05580367
NCT05580367招募中不适用

Gut-Brain-Axis/Lung-Brain-Axis and Mental Ill Health in Critical Illness

University Hospital Southampton NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Microbiome, metabolic changes and psychological symptoms

研究概览

简要总结

Survivors of critical illness commonly experience long-lasting cognitive, mental health and physical impairments. Clinically significant symptoms of anxiety, depression, and post-traumatic stress disorder (PTSD) may occur in 40%, 34% and 20% of ICU survivors respectively, compared to 6%, 8% and 4% in the general population. These symptoms can persist for more than 8 years.

Evidence shows the existence of a two-way, communication network between gut microbes and the brain referred to as the gut-brain axis. Changes in the microbiome and dysregulation of this communication network in relatively healthy people is associated with cognitive dysfunction and mood disorders such as anxiety and depression. The physiological stress associated with critical illness itself and many ICU interventions including the use of mechanical ventilation and medications such as antibiotics, antacids, vasopressors, and steroids can influence the balance of the gut microbiome and associated metabolites.

This observation study aims to:

  1. Quantify and measure dynamic changes in the gut microbiome and its metabolites during critical illness and recovery.
  2. Explore the associations between microbiome and metabolomic changes during critical illness and psychological symptoms in the patient during their recovery.

This knowledge will provide the potential to create interventions that alter the gut environment and microbiome both during and following a critical illness in order to reduce long-term adverse psychological effects. Examples of such potential interventions include dietary modifications with the use of prebiotics or probiotics.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Unplanned admission to critical care
  • Aged ≥18 years old
  • Requiring mechanical ventilation
  • Commencing ventilation within the previous 24 hours
  • Expected to be ventilated for minimum of ≥72 hours

排除标准

  • Known prior diagnosis of cognitive impairment
  • Known prior mental ill health
  • Known malignancy
  • Admitted after presenting with any of the following conditions:
  • brain injury
  • cardiac arrest
  • immunosuppressed
  • underlying pyogenic infection
  • Not expected to survive to completion of the study

结局指标

主要结局

Microbiome, metabolic changes and psychological symptoms

时间窗: 3 months post-discharge

Explore the associations between microbiome and metabolomic changes during critical illness and psychological symptoms in the patient during their recovery.

Gut microbial and metabolic signatures

时间窗: 3 months post-discharge

Investigate the potential for gut microbial and metabolic signatures at admission and discharge to predict the future development of psychological symptoms following ICU discharge.

Sample repository

时间窗: 3 months post-discharge

Establish a sample repository for future analysis for future studies.

Gut microbiome changes

时间窗: 3 months post-discharge

Quantify and measure dynamic changes in the gut microbiome and its metabolites during critical illness and recovery. (The number and diversity of microbe present)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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