NCT04455061

Intestinal Flora Research Plan for Critically Ill Patients

Status unknown Last updated 2 July 2020

What this trial tests

trial in Gut Microbiota, PICS in 300 participants. Status unknown.

Timeline

1 January 2020

Primary endpoint
30 December 2022

30 December 2022

Quick facts

Lead sponsor	Chinese Medical Association
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	300
Start date	1 January 2020
Primary completion	30 December 2022
Estimated completion	30 December 2022
Sites	1 location across China

Conditions studied

• Gut Microbiota, PICS — all drugs for Gut Microbiota, PICS →

Sponsor

Chinese Medical Association

Who can join

Adults 18 to 75, any sex, with Gut Microbiota, PICS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

More and more critically ill patients have improved early survival, they have been suffering from organ damage and inflammation for a long time, which is called chronic critical illness (CCI). Among CCI, persistent inflammatory response-immunosuppression-catabolic syndrome (PICS) is a special type of chronic severe disease, and immune paralysis is its main feature. The clinical manifestations are repeated nosocomial infections, malnutrition, muscle loss, and difficulty in wound healing and require long-term emergency medical support, which ultimately leads to patients Repeated nosocomial infections, prolonged hospitalization, and increased mortality.

The gut provides the microbiome with habitat and the nutrients it needs, down-regulates the immune response to form immune tolerance, and promotes its colonization in the intestine.Under physiological conditions, the mutually beneficial symbiosis of the intestine and microorganisms promotes the body's homeostasis. The composition and biodiversity of the microbial community are highly susceptible to various factors, including diet, environment, drugs, infections, inflammation, etc. Especially for acute stress, severe stress, the use of broad-spectrum antibiotics, vasoconstrictors and opioids, intestinal ischemia/reperfusion injury, epithelial cell apoptosis, barrier integrity destruction, gastrointestinal Changes in the motility of the tract, lack of nutrients in the intestinal cavity, etc. All those can lead to rapid changes in the intestinal flora, and this change can last for a long time; manifested by the loss of the richness and diversity of the intestinal microflora (especially the symbiotic flora), The ratio of Bacteroidetes/thickwalled bacteria is severely unbalanced, and a single flora (often a potential pathogen) overgrows, that is, bacterial flora imbalance or microecological disturbance.

At present, for critically ill patients, there are few relevant studies, and currently limited to small-scale, single cross-sectional studies. These studies have uncovered the changes and impacts of intestinal microbiota in critically ill patients in ICU, but they are still in the stage of touching the image of blind people. The relevant mechanisms and dynamic changes and their significance are unclear, requiring large-scale, dynamic, continuous and comprehensive In order to accurately grasp the role of intestinal flora in the development and prognosis of the disease, we hope to accurately control the intestinal flora and achieve effective treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.