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

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllShanghai University of Traditional Chinese Medici…
NCT07342205 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 o

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * Indications for exclusion from FMT (Fecal Microbiota Transplantation) include massive gastrointestinal bleeding, intestinal obstruction, organic intestinal disorders, and severe damage to intestinal mucosa; * Individuals with severe immune deficiencies, such as those with AIDS, leukemia, and those using immunosuppressive drugs; * Pregnant women and lactating women; * Those who cannot undergo nasal-intestinal catheterization or other transplantation methods; * Patients who cannot cooperate to complete the study; Other situations where the researchers determine that a patient is not suitable for participating in the clinical trial.
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What it tests

  • Placebo control group
  • Human-derived active intestinal bacterial liquid group
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Where

1 site
Putuo Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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