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A Prospective, Single-center, Randomized, Double-blind Controlled Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation
Led by Shanghai University of Traditional Chinese Medicine · Updated on 2026-01-15
60
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
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.
CONDITIONS
Brief Title
A Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clear or suspected infection plus SOFA score of 2 or higher
- PaO2/FiO2 ratio of 300 mmHg or less
- Able to take in nutrients by eating independently or enteral nutrition
- Willing to participate and sign informed consent form
You will not qualify if you...
- Massive gastrointestinal bleeding, intestinal obstruction, organic intestinal disorders, or severe intestinal mucosa damage
- Severe immune deficiencies such as AIDS, leukemia, or use of immunosuppressive drugs
- Pregnant or breastfeeding women
- Unable to undergo nasal-intestinal catheterization or other transplantation methods
- Unable to cooperate to complete the study
- Other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive basic treatment and are randomly assigned to receive either a human-derived active intestinal bacterial liquid or a placebo through nasal tube infusion as part of their treatment for acute lung injury caused by sepsis.
Visits on Days 0, 3, 7, 14, and 28
Trial Site Locations
Total: 1 location
1
Putuo Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Putuo, China, 421000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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