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

Sponsor
University Hospital Southampton NHS Foundation Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05580367
Collaborator
(none)
60
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Gut-Brain-Axis/Lung-Brain-Axis and Mental Ill Health in Critical Illness
    Anticipated Study Start Date :
    Nov 1, 2022
    Anticipated Primary Completion Date :
    Nov 1, 2024
    Anticipated Study Completion Date :
    Nov 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Gut microbiome changes [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)

    2. Microbiome, metabolic changes and psychological symptoms [3 months post-discharge]

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

    3. Gut microbial and metabolic signatures [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.

    4. Sample repository [3 months post-discharge]

      Establish a sample repository for future analysis for future studies.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital Southampton NHS Foundation Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Southampton NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT05580367
    Other Study ID Numbers:
    • RHM CRI0428
    First Posted:
    Oct 14, 2022
    Last Update Posted:
    Oct 14, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 14, 2022