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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05580367
• Other study ID #: RHM CRI0428
• Status: Recruiting
• Start date: February 14, 2023
• Est. completion date: November 2024

Study information

• Verified date: April 2023
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: Rebecca Cusack
• Phone: 023 8120 5308
• Email: rebecca.cusack[@]uhs.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Known prior diagnosis of cognitive impairment

• Known prior mental ill health

• Known malignancy

• Admitted after presenting with any of the following conditions:

• trauma

• brain injury

• surgery

• cardiac arrest

• immunosuppressed

• underlying pyogenic infection

• Not expected to survive to completion of the study

Related Conditions & MeSH terms

• Critical Illness
• Gut Microbiome
• Mental Health Issue

Locations

Country	Name	City	State
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiome changes	Quantify and measure dynamic changes in the gut microbiome and its metabolites during critical illness and recovery. (The number and diversity of microbe present)	3 months post-discharge
Primary	Microbiome, metabolic changes and psychological symptoms	Explore the associations between microbiome and metabolomic changes during critical illness and psychological symptoms in the patient during their recovery.	3 months post-discharge
Primary	Gut microbial and metabolic signatures	Investigate the potential for gut microbial and metabolic signatures at admission and discharge to predict the future development of psychological symptoms following ICU discharge.	3 months post-discharge
Primary	Sample repository	Establish a sample repository for future analysis for future studies.	3 months post-discharge