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

NCT07342205 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-15

No results posted yet for this study

Summary

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.

Conditions

  • Acute Respiratory Distress Syndrome (ARDS)
  • Acute Lung Injury(ALI)
  • Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome

Interventions

OTHER

Placebo control group

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.

OTHER

Human-derived active intestinal bacterial liquid group

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.

Sponsors & Collaborators

  • Shanghai University of Traditional Chinese Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07342205 on ClinicalTrials.gov