Putuo Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Putuo, 421000, China
Location status: Recruiting
NCT Number: NCT07342205
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Shanghai, Putuo, 421000, China
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 0-28 days
Oxygenation index (PaO2/FiO2),
Time frame: 0-28day
28-day all-cause mortality rate
Time frame: 0-28day
ICU hospitalization time
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),
Time frame: Day 0,3,7,14
Vital signs to be monitored as safety and physiological outcome measures
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),
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.
Time frame: Day0, 3, 7, 14
Oxidative stress biomarkers to be measured.
Time frame: Day0, 3, 7, 14
Myocardial enzyme profile outcome measures.
Time frame: Day0, 3, 7, 14
SOFA Score Calculation
Time frame: (Day0, 3, 7, 14)
procalcitonin (PCT, measured in ng/mL via chemiluminescent immunoassay),
Time frame: (Day0, 3, 7, 14)
tumor necrosis factor-alpha (TNF-α, measured in pg/mL via enzyme-linked immunosorbent assay).
Shanghai University of Traditional Chinese Medicine
Other
A Prospective, Single-center, Randomized, Double-blind Controlled Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation
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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