Treating sepsis-related acute lung injury with gut microbiota transplantation
A Prospective, Single-center, Randomized, Double-blind Controlled Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation
The team will test whether transplanting healthy gut bacteria can help adults with sepsis-related acute lung injury or ARDS recover better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai University of Traditional Chinese Medicine Academic / other |
| Locations | 1 site (Shanghai, Putuo) |
| Trial ID | NCT07342205 on ClinicalTrials.gov |
What this trial studies
This Phase 2/3 interventional trial gives adults with sepsis-related ALI/ARDS either a human-derived intestinal bacterial liquid or a placebo alongside standard care. The microbiota product is delivered via nasal-intestinal catheter or other transplantation methods while safety, lung function, and organ support needs are monitored. Researchers will analyze changes in the gut-lung microbiome, metabolic markers, and immune responses to map the microbial-metabolism-immune regulatory network. Clinical outcomes such as oxygenation (PaO2/FiO2), organ failure scores, and survival will be tracked to determine whether the treatment improves recovery.
Who should consider this trial
Good fit: Adults (≥18 years) with confirmed or suspected infection, SOFA score ≥2, and PaO2/FiO2 ≤300 mmHg who can take enteral nutrition and provide informed consent are the intended participants.
Not a fit: Patients with major gastrointestinal contraindications to FMT, severe immunodeficiency, pregnant or breastfeeding women, or those unable to undergo nasal-intestinal catheterization are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce lung injury and improve survival or recovery for patients with sepsis-related ALI/ARDS.
How similar studies have performed: Animal experiments and small clinical reports indicate potential benefit of FMT on the gut-lung axis, but high-quality clinical evidence for sepsis-related lung injury is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Putuo
- Putuo Hospital, Shanghai University of Traditional Chinese Medicine — Shanghai, Putuo, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.