Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Location contact
Jiancheng Zhang, Dr.
CONTACT
NCT Number: NCT06970262
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Wuhan, China
Jiancheng Zhang, Dr.
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Within 28 days after inclusion
The mortality rate within 28 days after inclusion in the study
Time frame: Within 24 hours before FMT intervention, and on days 1, 2, 3, 4, 5, 6 and 7 after FMT initiation
Change in total SOFA score from randomization (baseline) to 168 hours post-intervention
Time frame: Within 24 hours before FMT intervention, and at 72 hours after last FMT administration
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.
Time frame: Within 24 hours before FMT intervention, and at 72 hours and 28 days after FMT initiation
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.
Time frame: Within 24 hours before FMT intervention, and at 72 hours after FMT initiation
Serum samples were collected for metabolomics analysis to comprehensively examine the composition and changes of endogenous small molecule metabolites in the blood.
Time frame: Within 24 hours before FMT intervention, and on days 1, 2, 3, 4, 5, 6 and 7 after FMT initiation
Change in the respiratory subscore of SOFA from randomization (baseline) to 168 hours post-intervention
Time frame: Within 24 hours before FMT intervention, and at 72 hours after last FMT administration
The results obtained from metagenomic and metabolomic analyses of rectal swabs and BALF were used to explore the relationship between the two
Time frame: Within 24 hours before FMT intervention, and on days 1, 2, 3, 4, 5, 6 and 7 after FMT initiation
The determination of serum Citrulline is used as an indicator for evaluating intestinal barrier function.
Time frame: Within 24 hours before FMT intervention, and on days 1-7 after inclusion
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.
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
Mortality rate in ICU
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
Mortality rate during hospitalization
Time frame: Within 90 days after inclusion
The mortality rate within 90 days after inclusion in the study
Time frame: Within 90 days after inclusion
The proportion of patients readmitted within 90 days after discharge among those enrolled in the study
Time frame: Within 90 days after inclusion
The incidence of secondary pulmonary infection within 90 days following study enrollment
Contact information is provided by the study sponsor or research team.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Other
FMT for Lung and Associated-organ Rescue Efficacy in Multidrug-resistant Organism (MDRO)-Infected Ventilated Patients: a Single-center, Open-Label, Randomized Controlled Trial
Acronym: FLARE-MV
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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