Acute Respiratory Distress Syndrome (ARDS)Phase 2/3NCT07342205
A Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation
A Phase 2/3 study testing Human-derived active intestinal bacterial liquid group in people with Acute Respiratory Distress Syndrome (ARDS) and Acute Lung Injury(ALI), run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Acute Lung Injury(ALI), Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome
- What is being tested?
- Human-derived active intestinal bacterial liquid group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2025to Jun 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Putuo Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Putuo, 421000
sun yuting Dr, 19821758594, syt_354@163.com
About this study
Official title: A Prospective, Single-center, Randomized, Double-blind Controlled Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation
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.
Read the detailed description
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.
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), Acute Lung Injury(ALI), Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome
- Being tested
- Placebo control group, Human-derived active intestinal bacterial liquid group
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo control groupOther
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 groupOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Human-derived active intestinal bacterial liquid group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy evaluation
Oxygenation index (PaO2/FiO2),
Measured: 0-28 days
Efficacy evaluation
28-day all-cause mortality rate
Measured: 0-28day
Efficacy evaluation
ICU hospitalization time
Measured: 0-28day
Secondary outcomes (9)
Inflammatory markers
The inflammatory biomarkers to be assessed include serum levels of C-reactive protein (CRP, measured in mg/L via immunoturbidimetric assay),
Measured: (Day0, 3, 7, 14)
Vital signs (Day0 - 14)
Vital signs to be monitored as safety and physiological outcome measures
Measured: 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),
Measured: 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.
Measured: Day0, 7, 28
Oxidative stress indicators
Oxidative stress biomarkers to be measured.
Measured: Day0, 3, 7, 14
Functions of major organs
Myocardial enzyme profile outcome measures.
Measured: Day0, 3, 7, 14
SOFA score
SOFA Score Calculation
Measured: Day0, 3, 7, 14
Inflammatory markers
procalcitonin (PCT, measured in ng/mL via chemiluminescent immunoassay),
Measured: (Day0, 3, 7, 14)
Inflammatory markers
tumor necrosis factor-alpha (TNF-α, measured in pg/mL via enzyme-linked immunosorbent assay).
Measured: (Day0, 3, 7, 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start10 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Yuting, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342205
- Sponsor's protocol ID
- PTEC-R-2025-44-1
- Status last verified
- Jan 2026
- First submitted
- 31 Aug 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Randomized, Double-blind Controlled Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation
- ClinicalTrials.gov ID
- NCT07342205
- Acronym / sponsor ID
- PTEC-R-2025-44-1
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), Acute Lung Injury(ALI), Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Evaluation of the clinical efficacy and mechanism of action of fecal microbiota transplantation (FMT | Placebo comparator | Other: Placebo control groupThe 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. |
| Human-derived active intestinal bacterial liquid | Experimental | Other: Human-derived active intestinal bacterial liquid groupThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo control groupThe 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. | Other | Evaluation of the clinical efficacy and mechanism of action of fecal microbiota transplantation (FMT |
| Human-derived active intestinal bacterial liquid groupThe 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. | Other | Human-derived active intestinal bacterial liquid |
Primary outcome
Efficacy evaluation
Time frame: 0-28 days
Oxygenation index (PaO2/FiO2),
Efficacy evaluation
Time frame: 0-28day
28-day all-cause mortality rate
Efficacy evaluation
Time frame: 0-28day
ICU hospitalization time
9 secondary outcomes
Inflammatory markers
Time frame: (Day0, 3, 7, 14)
Vital signs (Day0 - 14)
Time frame: Day 0，3，7，14
Changes in intestinal flora
Time frame: Day0, 7, 28
Incidence of multi-drug resistant bacteria
Time frame: Day0, 7, 28
Oxidative stress indicators
Time frame: Day0, 3, 7, 14
Functions of major organs
Time frame: Day0, 3, 7, 14
SOFA score
Time frame: Day0, 3, 7, 14
Inflammatory markers
Time frame: (Day0, 3, 7, 14)
Inflammatory markers
Time frame: (Day0, 3, 7, 14)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Putuo Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Human-derived active intestinal bacterial liquid group in people with Acute Respiratory Distress Syndrome (ARDS) and Acute Lung Injury(ALI), run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy evaluation (time frame: 0-28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.