Treating sepsis-related acute lung injury with gut microbiota transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Putuo Hospital, Shanghai University of Traditional Chinese Medicine
  Shanghai, Putuo, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.