A Phase 2/3 interventional study of Placebo control group and Human-derived active intestinal bacterial liquid group in Acute Respiratory Distress Syndrome (ARDS), Acute Lung Injury(ALI) and Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome, sponsored by Shanghai University of Traditional Chinese Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Shanghai University of Traditional Chinese Medicine · Phase 2/3, Interventional, and Treatment
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.
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.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Shanghai University of Traditional Chinese Medicine is the lead sponsor of 102 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Efficacy evaluation
Oxygenation index (PaO2/FiO2),
Time frame: 0-28 days
Efficacy evaluation
28-day all-cause mortality rate
Time frame: 0-28day
Efficacy evaluation
ICU hospitalization time
Time frame: 0-28day
Inflammatory markers
The inflammatory biomarkers to be assessed include serum levels of C-reactive protein (CRP, measured in mg/L via immunoturbidimetric assay),
Time frame: (Day0, 3, 7, 14)
Vital signs (Day0 - 14)
Vital signs to be monitored as safety and physiological outcome measures
Time frame: Day 0，3，7，14
Changes in intestinal flora
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
Incidence of multi-drug resistant bacteria
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, 7, 28
Oxidative stress indicators
Oxidative stress biomarkers to be measured.
Time frame: Day0, 3, 7, 14
Functions of major organs
Myocardial enzyme profile outcome measures.
Time frame: Day0, 3, 7, 14
SOFA score
SOFA Score Calculation
Time frame: Day0, 3, 7, 14
Inflammatory markers
procalcitonin (PCT, measured in ng/mL via chemiluminescent immunoassay),
Time frame: (Day0, 3, 7, 14)
Inflammatory markers
tumor necrosis factor-alpha (TNF-α, measured in pg/mL via enzyme-linked immunosorbent assay).
Time frame: (Day0, 3, 7, 14)
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Respiratory Distress Syndrome →
Shanghai University of Traditional Chinese Medicine →