Mental Health IssueNCT05580367
Gut-Brain-Axis/Lung-Brain-Axis and Mental Ill Health in Critical Illness
An observational study of Mental Health Issue and Critical Illness, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Issue, Critical Illness, Gut Microbiome
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2023to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an unplanned admission to critical care who are mechanically ventilated
Who may be able to join
- 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
Who cannot join
- 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
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- surgery
- cardiac arrest
- immunosuppressed
- underlying pyogenic infection
- Not expected to survive to completion of the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton
Rebecca Cusack
About this study
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.
Read more
This observation study aims to:
- Quantify and measure dynamic changes in the gut microbiome and its metabolites during critical illness and recovery.
- 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
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months post-discharge
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.
Measured: 3 months post-discharge
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.
Measured: 3 months post-discharge
Sample repository
Establish a sample repository for future analysis for future studies.
Measured: 3 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start14 Feb 2023
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580367
- Sponsor's protocol ID
- RHM CRI0428
- Status last verified
- Apr 2023
- First submitted
- 11 Oct 2022
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut-Brain-Axis/Lung-Brain-Axis and Mental Ill Health in Critical Illness
- ClinicalTrials.gov ID
- NCT05580367
- Acronym / sponsor ID
- RHM CRI0428
- Conditions
- Mental Health Issue, Critical Illness, Gut Microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Quantify and measure dynamic changes in the gut microbiome and its metabolites during critical illness and recovery.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an unplanned admission to critical care who are mechanically ventilated
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- Known prior diagnosis of cognitive impairment
- Known prior mental ill health
- Known malignancy
- Admitted after presenting with any of the following conditions:
- trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut microbiome changes
Time frame: 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)
Microbiome, metabolic changes and psychological symptoms
Time frame: 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
Time frame: 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
Time frame: 3 months post-discharge
Establish a sample repository for future analysis for future studies.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue and Critical Illness, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Cusack (023 8120 5308, rebecca.cusack@uhs.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome changes (time frame: 3 months post-discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.