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

NCT07342205 | Recruiting Phase 2

• 1 other identifier: PTEC-R-2025-44-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Efficacy evaluation

  Oxygenation index (PaO2/FiO2),

  0-28 days

• Efficacy evaluation

  28-day all-cause mortality rate

  0-28day

• Efficacy evaluation

  ICU hospitalization time

  0-28day

Secondary Outcomes (9)

• Inflammatory markers

  (Day0, 3, 7, 14)

• Vital signs (Day0 - 14)

  Day 0，3，7，14

• Changes in intestinal flora

  Day0, 7, 28

• Incidence of multi-drug resistant bacteria

  Day0, 7, 28

• Oxidative stress indicators

  Day0, 3, 7, 14

Study Arms (2)

Evaluation of the clinical efficacy and mechanism of action of fecal microbiota transplantation (FMT

PLACEBO COMPARATOR

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

Other: Placebo control group

Human-derived active intestinal bacterial liquid

EXPERIMENTAL

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. Two groups were infused with the corresponding bacterial solution and the placebo bacterial solution through the nasal tube.

Other: Human-derived active intestinal bacterial liquid group

Interventions

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.

Evaluation of the clinical efficacy and mechanism of action of fecal microbiota transplantation (FMT

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.

Human-derived active intestinal bacterial liquid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (1)

Putuo Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Putuo, 421000, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: This study enrolled 60 patients with sepsis-related ALI who met the inclusion criteria. They were numbered using a random number table and randomly divided into Group A and Group B. Group A received basic treatment plus placebo (provided by Shanghai Baoteng Medical Laboratory, specification: 50 mL per bottle, number: 250713-DZ), while Group B received basic treatment plus FMT (provided by Shanghai Baoteng Medical Laboratory, specification: 50 mL per bottle, number: 250713-GT122. The donor screening followed international standards and there were no resistant bacteria or infectious pathogens). Note: Basic treatment included antibiotics, fluid resuscitation and respiratory support. Both groups received the corresponding bacterial solution and normal saline through the nasal intestinal tube, 100 mL each time, for 6 consecutive days. Oxygenation index (PaO2/FiO2), 28-day all-cause mortality rate and ICU hospitalization time were the main efficacy evaluation indicators. Adverse reactions ca

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: January 15, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

CN (1)