Study of Fecal Microbiota Transplantation to Treat Acute Lung Injury Caused by Sepsis A Randomized, Double-Blind Trial Evaluating Safety and Effectiveness

What this Trial Is About

Sepsis is a serious condition caused by infection that can lead to severe lung problems such as acute lung injury ALI and acute respiratory distress syndrome ARDS, which have high mortality rates between 30% and 50%. Current treatments do not effectively reduce deaths from sepsis-related lung injury, and no specific therapies target the lung damage itself. Research suggests that imbalances in gut bacteria play a key role in this condition, and fecal microbiota transplantation FMT may help by restoring healthy gut flora, though its effects and safety require more evidence. This study compares two groups of patients with sepsis-related ALI one group receives standard care plus a placebo, while the other receives standard care plus a human-derived active intestinal bacterial liquid. Both treatments are given through nasal tube infusion. The study aims to explore how gut bacteria affect the lung injury and to develop new microbiota transplantation strategies for treatment. This research is conducted as a single-center, randomized, double-blind controlled trial. Participants will be monitored for 28 days to evaluate treatment effectiveness using clinical measures such as inflammatory markers, vital signs, organ function, and changes in intestinal flora. Assessments occur at several time points including days 0, 3, 7, 14, and 28. Safety and efficacy data will be collected to better understand the role of microbiota transplantation in managing sepsis-related lung injury. The study duration and follow-up allow detailed observation of outcomes and potential benefits.

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