Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Considering that intestinal microbiota plays a crucial role in intestinal function, fecal microbiota transplantation (FMT) may provide a new therapeutic strategy for the treatment of intestinal nutrition intolerance in critically ill ICU patients. The purpose of this study was to investigate the effects of FMT on the recovery of gastrointestinal dysfunction-induced enteral nutrition intolerance in critically ill patients admitted to ICU, and observe the effects on gastrointestinal barrier function, as well as the effects on length of stay in ICU, ICU mortality, in-hospital mortality, and 28-day mortality.
Patients in the intensive care unit (ICU) are often at risk for gastrointestinal dysfunction and malnutrition. Gastrointestinal dysfunction is associated with poorer clinical outcomes, including longer mechanical ventilation, longer ICU stay, and increased 90-day mortality. Due to the influence of primary severe diseases and the use of proton pump inhibitors (PPI) and antibiotics, ICU patients with severe illness may have severe disturbance of intestinal flora, impairment of intestinal barrier function, high incidence of gastrointestinal dysfunction-induced enteral nutrition intolerance, and severe intestinal systemic inflammation and organ function injury. Considering that intestinal microbiota plays a crucial role in intestinal function, fecal microbiota transplantation (FMT) may provide a new therapeutic strategy for the treatment of gastrointestinal dysfunction-induced enteral nutrition intolerance in critically ill ICU patients. The project plans through nasal jejunal tube way to give FMT, to investigate its effect on the recovery of gastrointestinal dysfunction-induced enteral nutrition intolerance in severe patients admitted to ICU, and to observe its effect on gastrointestinal barrier function.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT intervention Group | Experimental | In addition to ICU standard treatment, 50ml commercial intestinal bacterial suspension was administered via a naso-jejunal tube to the jejunum from 11:00 to 13:00 every day for 3 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation (FMT) by nasal jejunal tube | Biological | FMT was administered via a naso-jejunal tube to inject 50ml commercial intestinal bacterial suspension into the jejunum. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of the effective improvement of enteral nutrition intolerance | Change of intestinal nutrition intolerance. | 24, 48, 72 and 96 hours after first FMT. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of intestinal microbiota and its metabolites | Rectal swab was taken and analysed by 16S rRNA gene sequencing and metabolomics. | -48, 72 and 96 hours after first FMT. |
| Intestinal barrier function |
Not provided
Inclusion criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jiancheng Zhang, Dr. | Wuhan Union Hospial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
2ml of peripheral venous blood was collected for the measurement of serum lipopolysaccharide (LPS), diamine oxidase (DAO), and D-lactic acid.
| -24, 0, 24, 48, 72 and 96 hours after first FMT. |
| Acute Physiology and Chronic Health Evaluation (APACHE) Ⅱ score | Acute Physiology and Chronic Health Evaluation (APACHE) Ⅱ score is a scoring system used to assess the severity of critically ill patients. APACHE II score ranges from 0 to 71. The higher the score, the greater the severity and the poorer the prognosis. | -48, -24, 0, 24, 48, 72 and 96 hours after first FMT. |
| C-reactive protein (CRP) | 2ml of peripheral venous blood was collected for the measurement of CRP. | -48, -24, 0, 24, 48, 72 and 96 hours after first FMT. |
| Peripheral blood cytokines and lymphocyte subsets | 2ml of peripheral venous blood was collected for the measurement of the levels of cytokines and the absolute number of lymphocyte subsets. | -24 and 72 hours after inclusion. |
| 28-day mortality | Mortality rate of patients in each group within 28 days after inclusion. | 28 days after inclusion. |
| 90-day mortality | Mortality rate of patients in each group within 90 days after inclusion. | 90 days after inclusion. |
| Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided