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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Age ≥ 18 years;

• Clear or suspected infection + SOFA score ≥ 2 points, and PaO₂/FiO₂ ≤ 300 mmHg;

• Capable of taking in nutrients (able to eat independently or receive enteral nutrition);

• Voluntarily participate in this trial and sign the informed consent form.

Locations
Other Locations
China
Putuo Hospital, Shanghai University of Traditional Chinese Medicine
RECRUITING
Shanghai
Time Frame
Start Date: 2025-12-10
Estimated Completion Date: 2027-06
Participants
Target number of participants: 60
Treatments
Placebo_comparator: Evaluation of the clinical efficacy and mechanism of action of fecal microbiota transplantation (FMT
The participants in this study will be divided into Group A and Group B. The participants in Group A will receive basic treatment and a placebo (provided by Shanghai Baoteng Medical Laboratory, specification: 50 mL per bottle, serial number: 250713-DZ) for treatment.
Experimental: Human-derived active intestinal bacterial liquid
The participants in Group B will receive basic treatment and human-derived active intestinal flora liquid (provided by Shanghai Baoteng Medical Laboratory, specification: 50 mL per bottle, serial number: 250713-GT122) for treatment. Two groups were infused with the corresponding bacterial solution and the placebo bacterial solution through the nasal tube.
Sponsors
Leads: Shanghai University of Traditional Chinese Medicine

This content was sourced from clinicaltrials.gov