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

NCT ID: NCT05580367

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-14
• Study Completion Date: 2024-11-30

Brief 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.

Conditions

Mental Health Issue; Critical Illness; Gut Microbiome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Southampton NHS Foundation Trust

Southampton, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Rebecca Cusack

Role: CONTACT

rebecca.cusack@uhs.nhs.uk

023 8120 5308

Facility Contacts

Rebecca Cusack

Role: primary

Other Identifiers

RHM CRI0428

Identifier Type: -

Identifier Source: org_study_id