Lung InfectionFLARE-MVNCT06970262

FMT for Lung and Associated-organ Rescue Efficacy in MDRO-infected Ventilated Patients

A study testing Fecal suspension in people with Lung Infection and Microbial Colonization, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Lung Infection, Microbial Colonization, Food Intolerance Syndromes
What is being tested?: Fecal suspension
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteChina
Study dates: 20 Sep 2026to 31 Dec 2027
Phase: Interventional
Are there results?: None posted in the registry

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-70 years, inclusive, irrespective of sex or ethnic background;
Admission to the intensive care unit (ICU) within 24-48 hours;
Anticipated ICU length of stay of ≥7 days, as determined by the attending intensivist prior to enrollment;
Mechanically ventilated patients with MDRO infection;
Provision of written informed consent by the participant or legally authorized representative.

Who cannot join

Severe systemic infection during early resuscitation, accompanied by hemodynamic instability, profound tissue hypoperfusion, or life-threatening electrolyte and acid-base disturbances;
Clinician-assessed high risk of mortality within 5 days, or presence of formal treatment-limiting directives (e.g., do-not-intubate or do-not-resuscitate orders);
Active gastrointestinal bleeding or perforation consistent with severe intestinal barrier dysfunction;
Inability to tolerate enteral nutrition providing ≥50% of estimated caloric requirements due to structural intestinal pathology-including fibrotic bowel stenosis or high-output enterocutaneous fistula;
Planned abdominal surgery or history of abdominal surgery within 14 days prior to enrollment;
Confirmed diagnosis of fulminant colitis or toxic megacolon;

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Neutropenia defined as absolute neutrophil count < 1.5 × 10⁹/L;
Recent exposure to high-risk immunosuppressive or cytotoxic agents within the preceding 3 months, including but not limited to: rituximab (within 6 months), anthracyclines (e.g., doxorubicin), or systemic corticosteroids at ≥20 mg/day prednisone-equivalent dose for ≥4 consecutive weeks;
Pregnancy or lactation;
Participation in another interventional clinical trial within 3 months prior to enrollment or ongoing at the time of study entry.

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan

Other trials in China

About this study

Official title: FMT for Lung and Associated-organ Rescue Efficacy in Multidrug-resistant Organism (MDRO)-Infected Ventilated Patients: a Single-center, Open-Label, Randomized Controlled Trial

Multidrug-resistant organism (MDRO)-infection represents a substantial global health burden. In the intensive care unit (ICU), the concurrent administration of antibiotics, opioids, proton pump inhibitors (PPIs), vasoconstrictors, and parenteral nutrition-compounded by the intrinsic severity of critical illness-induces profound gut microbiota dysbiosis. Accumulating preclinical and clinical evidence indicates that such intestinal dysregulation may trigger distal immunomodulatory and microbial shifts in the lung via the gut-lung axis, thereby contributing to pulmonary microecological imbalance and impairing recovery trajectories. Although pulmonary microecology has garnered increasing scientific attention, the causal and temporal relationship between gut dysbiosis and the establishment or exacerbation of pulmonary microbial dysbiosis in MDRO-infecction remains inadequately characterized. As a result, it is currently unclear whether gut dysbiosis serves as a primary pathogenic driver, a disease-amplifying factor, or a secondary epiphenomenon in the context of MDRO-infecction-associated lung injury.

Fecal microbiota transplantation (FMT) is a targeted microbiome-modulating intervention that involves the transfer of functionally diverse, minimally processed microbial communities from comprehensively screened healthy donors to restore ecological stability and functional redundancy in the recipient gut. Robust clinical data demonstrate that FMT effectively decolonizes the gastrointestinal tract of MDROs and reduces the incidence of secondary infections in immunocompetent, non-critically ill populations. Over the past decade, FMT has demonstrated reproducible efficacy in recurrent Clostridioides difficile infection and emerging promise in select extra-intestinal inflammatory conditions-highlighting its capacity as a mechanism-informed strategy for systemic host-microbe recalibration. Given the established role of the gut as a reservoir for enteric pathogens implicated in sepsis, hospital-acquired bloodstream infections, and ventilator-associated pneumonia (VAP), we propose a prospective, single-center, open-Label, randomized controlled trial (RCT) enrolling mechanically ventilated adults with MDRO-infeccted ventilated patients. The primary objective is to evaluate whether adjunctive FMT-delivered via nasojejunal tube-decrease 28-day mortality.

Conditions: Lung Infection, Microbial Colonization, Food Intolerance Syndromes
Being tested: Fecal suspension
Medical subject headings: Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fecal suspensionOther
Prepare 300 ml of intestinal flora suspension from 100-150 g of feces. Subjects can eat and drink freely during preparation but must fast for at least 2 hours before FMT (water allowed). No food or water is permitted within 2 hours after FMT.

Study groups in NCT06970262
Study group	Role	What they receive
FMT intervention group	Experimental	On the basis of the standard ICU treatment protocol, FMT was administered via a nasojejunal tube. Over three consecutive days, 50-100 ml of intestinal flora suspension was delivered through the nasojejunal tube daily between 11:00 and 13:00. Oral vancomycin, metronidazole, and microbiota-disrupting quinolones should be avoided, except when intravenous quinolones are required for MDRO treatment. Antifungals may continue due to minimal impact on gut bacteria. Receives: Other: Fecal suspension
Control group	No intervention	Receiving the standard ICU treatment protocol involves a comprehensive set of systematic and standardized medical and nursing interventions designed for critically ill patients in the ICU. These interventions are aimed at ensuring patient stability through multidisciplinary collaboration, continuous physiological monitoring, and functional support, while also facilitating recovery. The ICU treatment protocol is developed based on modern medical principles and extensive clinical experience, encompassing all aspects from fundamental care to advanced life support. The control group follows the same antibiotic rules. This ensures comparable anti-infective treatment intensity between groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

28-day all-cause mortality rate
The mortality rate within 28 days after inclusion in the study
Measured: Within 28 days after inclusion

Secondary outcomes (13)

Dynamic changes in the total SOFA score
Change in total SOFA score from randomization (baseline) to 168 hours post-intervention
Measured: Within 24 hours before FMT intervention, and on days 1, 2, 3, 4, 5, 6 and 7 after FMT initiation
Changes in pulmonary microbiota diversity
Metagenomics profiling of BALF was conducted to compare the pulmonary microbiota between the two groups. Metagenomic sequencing will be performed to analyze the dynamic changes in α-diversity (Shannon index), β-diversity, and the relative abundance of specific microbial taxa, including the Firmicutes-to-Bacteroidetes ratio, and potential pathogens.
Measured: Within 24 hours before FMT intervention, and at 72 hours after last FMT administration
Changes in intestinal microbiota diversity
Metagenomics profiling of rectal swabs was conducted to compare the gut microbiota between the two groups. Metagenomic sequencing will be performed to analyze the dynamic changes in α-diversity (Shannon index), β-diversity, and the relative abundance of specific microbial taxa, including the Firmicutes-to-Bacteroidetes ratio, and potential pathogens.
Measured: Within 24 hours before FMT intervention, and at 72 hours and 28 days after FMT initiation
Alterations in serum metabolites
Serum samples were collected for metabolomics analysis to comprehensively examine the composition and changes of endogenous small molecule metabolites in the blood.
Measured: Within 24 hours before FMT intervention, and at 72 hours after FMT initiation
Change in the respiratory subscore of SOFA
Change in the respiratory subscore of SOFA from randomization (baseline) to 168 hours post-intervention
Measured: Within 24 hours before FMT intervention, and on days 1, 2, 3, 4, 5, 6 and 7 after FMT initiation
Correlation between gut microbiota and pulmonary microecology
The results obtained from metagenomic and metabolomic analyses of rectal swabs and BALF were used to explore the relationship between the two
Measured: Within 24 hours before FMT intervention, and at 72 hours after last FMT administration
Serum Citrulline
The determination of serum Citrulline is used as an indicator for evaluating intestinal barrier function.
Measured: Within 24 hours before FMT intervention, and on days 1, 2, 3, 4, 5, 6 and 7 after FMT initiation
Changes of APACHE II score
The APACHE II scoring system serves as a critical tool for evaluating the clinical status and prognosis of ICU patients. This system comprises three components: the Acute Physiology Score (APS), the Age Score, and the Chronic Health Evaluation Score. The total score is derived by summing these three components. The theoretical maximum score is 71, with higher scores indicating more severe conditions. Notably, the APS encompasses 12 physiological parameters and introduces a formula for calculating the risk of death (R). By aggregating the R values of all patients and dividing by the total number of patients, the predicted mortality rate for the patient population can be estimated.
Measured: Within 24 hours before FMT intervention, and on days 1-7 after inclusion
ICU mortality rate
Mortality rate in ICU
Measured: From date of randomization until the date of discharge from the ICU or date of death from any cause during ICU stay, whichever came first, assessed up to 6 weeks
In-hospital mortality rate
Mortality rate during hospitalization
Measured: From date of randomization until the date of discharge from the hospital or date of death from any cause during hospitalization, whichever came first, assessed up to 6 weeks
90-day all-cause mortality rate
The mortality rate within 90 days after inclusion in the study
Measured: Within 90 days after inclusion
90-day post-discharge readmission rate
The proportion of patients readmitted within 90 days after discharge among those enrolled in the study
Measured: Within 90 days after inclusion
Secondary pulmonary infection rate within 90 days of study enrollment
The incidence of secondary pulmonary infection within 90 days following study enrollment
Measured: Within 90 days after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 202631 Dec 2027

First posted14 May 2025
Study start20 Sep 2026 (estimated)
Primary completion15 Nov 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Why it stopped: Strict eligibility criteria and complex protocol requirements have made enrollment infeasible; we therefore withdraw the registration.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung InfectionStudies of the same condition, open and under way.
More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06970262
Sponsor's protocol ID: 0928-01
Acronym: FLARE-MV
Status last verified: Aug 2026
First submitted: 24 Apr 2025
Last updated: 2 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: FMT for Lung and Associated-organ Rescue Efficacy in Multidrug-resistant Organism (MDRO)-Infected Ventilated Patients: a Single-center, Open-Label, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06970262
Acronym / sponsor ID: FLARE-MV / 0928-01
Conditions: Lung Infection, Microbial Colonization, Food Intolerance Syndromes
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Strict eligibility criteria and complex protocol requirements have made enrollment infeasible; we therefore withdraw the registration.
Enrolment: 0 participants (actual)
Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
Study start: 20 Sep 2026 (estimated)
Primary completion: 15 Nov 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 14 May 2025 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
FMT intervention group	Experimental	Other: Fecal suspensionOn the basis of the standard ICU treatment protocol, FMT was administered via a nasojejunal tube. Over three consecutive days, 50-100 ml of intestinal flora suspension was delivered through the nasojejunal tube daily between 11:00 and 13:00. Oral vancomycin, metronidazole, and microbiota-disrupting quinolones should be avoided, except when intravenous quinolones are required for MDRO treatment. Antifungals may continue due to minimal impact on gut bacteria.
Control group	No intervention	–Receiving the standard ICU treatment protocol involves a comprehensive set of systematic and standardized medical and nursing interventions designed for critically ill patients in the ICU. These interventions are aimed at ensuring patient stability through multidisciplinary collaboration, continuous physiological monitoring, and functional support, while also facilitating recovery. The ICU treatment protocol is developed based on modern medical principles and extensive clinical experience, encompassing all aspects from fundamental care to advanced life support. The control group follows the same antibiotic rules. This ensures comparable anti-infective treatment intensity between groups.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age 18-70 years, inclusive, irrespective of sex or ethnic background;
Admission to the intensive care unit (ICU) within 24-48 hours;
Anticipated ICU length of stay of ≥7 days, as determined by the attending intensivist prior to enrollment;
Mechanically ventilated patients with MDRO infection;
Provision of written informed consent by the participant or legally authorized representative.

Key exclusion criteria (10 listed)

Severe systemic infection during early resuscitation, accompanied by hemodynamic instability, profound tissue hypoperfusion, or life-threatening electrolyte and acid-base disturbances;
Clinician-assessed high risk of mortality within 5 days, or presence of formal treatment-limiting directives (e.g., do-not-intubate or do-not-resuscitate orders);
Active gastrointestinal bleeding or perforation consistent with severe intestinal barrier dysfunction;
Inability to tolerate enteral nutrition providing ≥50% of estimated caloric requirements due to structural intestinal pathology-including fibrotic bowel stenosis or high-output enterocutaneous fistula;
Planned abdominal surgery or history of abdominal surgery within 14 days prior to enrollment;

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
Fecal suspensionPrepare 300 ml of intestinal flora suspension from 100-150 g of feces. Subjects can eat and drink freely during preparation but must fast for at least 2 hours before FMT (water allowed). No food or water is permitted within 2 hours after FMT.	Other	FMT intervention group

Primary outcome

28-day all-cause mortality rate
Time frame: Within 28 days after inclusion
The mortality rate within 28 days after inclusion in the study

13 secondary outcomes

Dynamic changes in the total SOFA score
Time frame: Within 24 hours before FMT intervention, and on days 1, 2, 3, 4, 5, 6 and 7 after FMT initiation
Changes in pulmonary microbiota diversity
Time frame: Within 24 hours before FMT intervention, and at 72 hours after last FMT administration
Changes in intestinal microbiota diversity
Time frame: Within 24 hours before FMT intervention, and at 72 hours and 28 days after FMT initiation
Alterations in serum metabolites
Time frame: Within 24 hours before FMT intervention, and at 72 hours after FMT initiation
Change in the respiratory subscore of SOFA
Time frame: Within 24 hours before FMT intervention, and on days 1, 2, 3, 4, 5, 6 and 7 after FMT initiation
Correlation between gut microbiota and pulmonary microecology
Time frame: Within 24 hours before FMT intervention, and at 72 hours after last FMT administration
Serum Citrulline
Time frame: Within 24 hours before FMT intervention, and on days 1, 2, 3, 4, 5, 6 and 7 after FMT initiation
Changes of APACHE II score
Time frame: Within 24 hours before FMT intervention, and on days 1-7 after inclusion
ICU mortality rate
Time frame: From date of randomization until the date of discharge from the ICU or date of death from any cause during ICU stay, whichever came first, assessed up to 6 weeks
In-hospital mortality rate
Time frame: From date of randomization until the date of discharge from the hospital or date of death from any cause during hospitalization, whichever came first, assessed up to 6 weeks
90-day all-cause mortality rate
Time frame: Within 90 days after inclusion
90-day post-discharge readmission rate
Time frame: Within 90 days after inclusion
Secondary pulmonary infection rate within 90 days of study enrollment
Time frame: Within 90 days after inclusion

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Lung Infection

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RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
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A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
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Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 2 Sep 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28-day all-cause mortality rate (time frame: Within 28 days after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06970262.

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 2 Sep 2026.