Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT05580367
Status:
UNKNOWN
Last Update Posted:
2023-04-14
First Post:
2022-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gut-Brain-Axis/Lung-Brain-Axis and Mental Ill Health in Critical Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gut microbiome changes', 'timeFrame': '3 months post-discharge', 'description': 'Quantify and measure dynamic changes in the gut microbiome and its metabolites during critical illness and recovery. (The number and diversity of microbe present)'}, {'measure': 'Microbiome, metabolic changes and psychological symptoms', 'timeFrame': '3 months post-discharge', 'description': 'Explore the associations between microbiome and metabolomic changes during critical illness and psychological symptoms in the patient during their recovery.'}, {'measure': 'Gut microbial and metabolic signatures', 'timeFrame': '3 months post-discharge', 'description': 'Investigate the potential for gut microbial and metabolic signatures at admission and discharge to predict the future development of psychological symptoms following ICU discharge.'}, {'measure': 'Sample repository', 'timeFrame': '3 months post-discharge', 'description': 'Establish a sample repository for future analysis for future studies.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health Issue', 'Critical Illness', 'Gut Microbiome']}, 'descriptionModule': {'briefSummary': '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.\n\nEvidence 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.\n\nThis observation study aims to:\n\n1. Quantify and measure dynamic changes in the gut microbiome and its metabolites during critical illness and recovery.\n2. Explore the associations between microbiome and metabolomic changes during critical illness and psychological symptoms in the patient during their recovery.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an unplanned admission to critical care who are mechanically ventilated', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unplanned admission to critical care\n* Aged ≥18 years old\n* Requiring mechanical ventilation\n* Commencing ventilation within the previous 24 hours\n* Expected to be ventilated for minimum of ≥72 hours\n\nExclusion Criteria:\n\n* Known prior diagnosis of cognitive impairment\n* Known prior mental ill health\n* Known malignancy\n* Admitted after presenting with any of the following conditions:\n* trauma\n* brain injury\n* surgery\n* cardiac arrest\n* immunosuppressed\n* underlying pyogenic infection\n* Not expected to survive to completion of the study'}, 'identificationModule': {'nctId': 'NCT05580367', 'briefTitle': 'Gut-Brain-Axis/Lung-Brain-Axis and Mental Ill Health in Critical Illness', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Southampton NHS Foundation Trust'}, 'officialTitle': 'Gut-Brain-Axis/Lung-Brain-Axis and Mental Ill Health in Critical Illness', 'orgStudyIdInfo': {'id': 'RHM CRI0428'}}, 'contactsLocationsModule': {'locations': [{'city': 'Southampton', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Rebecca Cusack', 'role': 'CONTACT'}], 'facility': 'University Hospital Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'centralContacts': [{'name': 'Rebecca Cusack', 'role': 'CONTACT', 'email': 'rebecca.cusack@uhs.nhs.uk', 'phone': '023 8120 5308'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Southampton NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}