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

NCT07342205 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai University of Traditional Chinese Medicine

Phase

Phase 2/3

Started

2025-12-10

Last updated

2026-01-15

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Placebo control groupHuman-derived active intestinal bacterial liquid group

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.

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.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Efficacy evaluation — 0-28 days
Oxygenation index (PaO2/FiO2),
Efficacy evaluation — 0-28day
28-day all-cause mortality rate
Efficacy evaluation — 0-28day
ICU hospitalization time

Trial sites (1)

Facility	City	Region	Status
Putuo Hospital, Shanghai University of Traditional Chinese Medicine	Shanghai	Putuo	Recruiting

More Shanghai University of Traditional Chinese Medicine trials in China

TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease Recruiting

The Association of Transgelin-2, Metallothionein-2 and Ezrin With Asthma Recruiting

Baduanjin Training for Depression and Anxiety Patients Recruiting

EOCRCPred: an AI Model to Predict Survival in EOCRC Patients After Surgery Starting soon

TCM Daoyin for Anxiety/Depression: Psychological Effects and Biological Mechanisms Recruiting

Other trials for the same condition

Electrical Impedance Tomography-Guided Identification of the Optimal Lateral Position in Postoperative ARDS Recruiting

RSPO3/SDC-1 Pathway Dysfunction in Alveolar Repair After ARDS in Older Adults Starting soon

The Feasibility of Pulmonary Perfusion Assessment Using Sodium Bicarbonate Contrast With Electrical Impedance Tomography: A Prospective Pilot Study Recruiting

Electrical Impedance Tomography-Based Prognostic Model for ARDS Recruiting

Dexamethasone Treatment for Sepsis-associated Acute Respiratory Distress Syndrome: a Multicenter, Randomised, Double-blinded, Controlled Trial Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07342205 on ClinicalTrials.gov ↗ ← All trials in China