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NCT Number: NCT07342205

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Putuo Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Putuo, 421000, China

Location status: Recruiting

Location contact

sun yuting Dr

CONTACT

[email protected]

19821758594

About this study

Although certain research progress has been made in the pathogenesis and treatment of sepsis-related lung injury, many unresolved issues still exist. 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 the lung injury itself. Dysbiosis of the intestinal flora plays an important role in the occurrence and development of sepsis-related lung injury, and FMT, as an effective means of regulating the intestinal flora, has shown certain therapeutic potential in animal experiments and 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, and there is a lack of high-quality evidence to support its clinical efficacy and safety. Therefore, conducting this project's research is of great necessity. Through this project's research, it is expected to analyze the microbial-metabolism-immune regulatory network in the gut-lung axis, providing theoretical basis for targeted microecological treatment of sepsis-related lung injury; establish a new strategy for treating sepsis ALI patients using combined microbiota transplantation technology, and provide new ideas and methods for clinical treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

placebo control group

Other

The participants in Group A will receive basic treatment and placebo (provided by Shanghai Baoteng Medical Laboratory, specification: 50 mL per bottle, serial number: 250713-DZ) for treatment.

Human-derived active intestinal bacterial liquid group

Other

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.

Primary outcomes

  1. Efficacy evaluation

    Time frame: 0-28 days

    Oxygenation index (PaO2/FiO2),

  2. Efficacy evaluation

    Time frame: 0-28day

    28-day all-cause mortality rate

  3. Efficacy evaluation

    Time frame: 0-28day

    ICU hospitalization time

Secondary outcomes

  1. Inflammatory markers

    Time frame: (Day0, 3, 7, 14)

    The inflammatory biomarkers to be assessed include serum levels of C-reactive protein (CRP, measured in mg/L via immunoturbidimetric assay),

  2. Vital signs (Day0 - 14)

    Time frame: Day 0,3,7,14

    Vital signs to be monitored as safety and physiological outcome measures

  3. Changes in intestinal flora

    Time frame: Day0, 7, 28

    Changes in gut microbiota will be assessed as a secondary outcome by performing 16S ribosomal RNA gene sequencing on stool samples collected at baseline (pre-treatment),

  4. Incidence of multi-drug resistant bacteria

    Time frame: Day0, 7, 28

    The primary/secondary outcome measure is the incidence of multidrug-resistant organism (MDRO) infection, defined as the proportion of patients who develop a new infection with bacteria resistant to at least one agent in three or more antimicrobial categories, confirmed by standard microbiological culture and antibiotic susceptibility testing.

  5. Oxidative stress indicators

    Time frame: Day0, 3, 7, 14

    Oxidative stress biomarkers to be measured.

  6. Functions of major organs

    Time frame: Day0, 3, 7, 14

    Myocardial enzyme profile outcome measures.

  7. SOFA score

    Time frame: Day0, 3, 7, 14

    SOFA Score Calculation

  8. Inflammatory markers

    Time frame: (Day0, 3, 7, 14)

    procalcitonin (PCT, measured in ng/mL via chemiluminescent immunoassay),

  9. Inflammatory markers

    Time frame: (Day0, 3, 7, 14)

    tumor necrosis factor-alpha (TNF-α, measured in pg/mL via enzyme-linked immunosorbent assay).

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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