Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
NCT07342205

A 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

76 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �318 years
  • Clear or suspected infection plus SOFA score �32 points
  • Blood oxygen level (PaO2/FiO2) �3300 mmHg
  • Able to eat independently or receive enteral nutrition
  • Willing to participate and sign informed consent
Not Eligible

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 with study procedures
  • Other conditions deemed unsuitable by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Putuo Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Putuo, China, 421000

Actively Recruiting

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