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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05580367
Enrollment
60
Registered
2022-10-14
Start date
2023-02-14
Completion date
2024-11-30
Last updated
2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Gut Microbiome, Mental Health Issue

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.

Interventions

None listed

Sponsors

University Hospital Southampton NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Gut microbiome changes3 months post-dischargeQuantify and measure dynamic changes in the gut microbiome and its metabolites during critical illness and recovery. (The number and diversity of microbe present)
Microbiome, metabolic changes and psychological symptoms3 months post-dischargeExplore the associations between microbiome and metabolomic changes during critical illness and psychological symptoms in the patient during their recovery.
Gut microbial and metabolic signatures3 months post-dischargeInvestigate the potential for gut microbial and metabolic signatures at admission and discharge to predict the future development of psychological symptoms following ICU discharge.
Sample repository3 months post-dischargeEstablish a sample repository for future analysis for future studies.

Countries

United Kingdom

Contacts

Primary ContactRebecca Cusack
rebecca.cusack@uhs.nhs.uk023 8120 5308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026