A Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation

Official title: A Prospective, Single-center, Randomized, Double-blind Controlled Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation

Summary: Sepsis is a systemic inflammatory response syndrome triggered by infection, and it is a common critical illness in clinical practice, often leading to multiple organ dysfunction. Among these, acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are among the most severe complications. The mortality rate of sepsis-related lung injury is extremely high, reaching 30% - 50%. The existing treatment methods are unable to effectively reduce the high mortality rate of sepsis-related lung injury, and there are no specific treatment measures targeting lung injury itself. Dysbiosis of the intestinal flora plays an important role in the occurrence and development of sepsis-related lung injury. Fecal microbiota transplantation (FMT), as an effective means of regulating the intestinal flora, has shown certain therapeutic potential in some clinical studies. However, current research on FMT for treating sepsis-related lung injury is still in its infancy, and its mechanism is not yet fully clear. The clinical efficacy and safety also lack high-quality evidence support. Therefore, conducting this project's research will provide theoretical basis for targeted microecological treatment of sepsis-related lung injury; establishing a new strategy of combined microbiota transplantation technology for treating patients with sepsis ALI, and providing new ideas and methods for clinical treatment.

Conditions: Acute Respiratory Distress Syndrome (ARDS), Acute Lung Injury(ALI), Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome

Study type: INTERVENTIONAL

Primary purpose: TREATMENT

Phases: PHASE2, PHASE3

Enrollment: 60 (ESTIMATED)

Status: RECRUITING

Completion: 2027-06 (ESTIMATED)