Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603883
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Efficacy of Fecal Microbiota Transplantation in ICU Patients With Gastrointestinal Dysfunction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Fecal Microbiota Transplantation in Critically Ill ICU Patients With Gastrointestinal Dysfunction a Single-center Non-blind Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 in critically ill ICU patients The purpose of this study was to investigate the effects of FMT on the recovery of gastrointestinal dysfunction 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
Detailed Description:
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 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 in critically ill ICU patients The project plans through nasal jejunal tube way to give FMT to investigate its effect on gastrointestinal function recovery in severe patients with gastrointestinal dysfunction admitted to ICU and to observe its effect on gastrointestinal barrier function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None