Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT05580367
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.
Study:
NCT05580367
Study Brief:
Protocol Section:
NCT05580367