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.
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;
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;
Parallel
Fecal suspension
Other interventionPrepare 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.
28-day all-cause mortality rate
The mortality rate within 28 days after inclusion in the study
Dynamic changes in the total SOFA score
Change in total SOFA score from randomization (baseline) to 168 hours post-intervention
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.
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.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
