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RECRUITING

NCT06970262

FMT for Lung and Associated-organ Rescue Efficacy in ARDS Patients

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

Acute respiratory distress syndrome (ARDS) 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 ARDS 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 ARDS-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 multidrug-resistant organisms (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 ARDS. The primary objective is to evaluate whether adjunctive FMT-delivered via nasojejunal tube-decrease 28-day mortality.

Official title: FMT for Lung and Associated-organ Rescue Efficacy in ARDS Patients: A Single-Center, Open-Label, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-04-15

Completion Date

2026-12-31

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Lung Infection Microbial Colonization Food Intolerance Syndromes

Interventions

OTHER

Fecal suspension

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.

Inclusion Criteria: 1. Age 18-70 years, inclusive, irrespective of sex or ethnic background; 2. Admission to the intensive care unit (ICU) within 48 hours; 3. Anticipated ICU length of stay of ≥7 days, as determined by the attending intensivist prior to enrollment; 4. Diagnosis of acute respiratory distress syndrome (ARDS) meeting the new global definition; 5. Provision of written informed consent by the participant or legally authorized representative. Exclusion Criteria: 1. Severe systemic infection during early resuscitation, accompanied by hemodynamic instability, profound tissue hypoperfusion, or life-threatening electrolyte and acid-base disturbances; 2. 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); 3. Active gastrointestinal bleeding or perforation consistent with severe intestinal barrier dysfunction; 4. 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; 5. Planned abdominal surgery or history of abdominal surgery within 14 days prior to enrollment; 6. Confirmed diagnosis of fulminant colitis or toxic megacolon; 7. Neutropenia defined as absolute neutrophil count \< 1.5 × 10⁹/L; 8. Known congenital or acquired immunodeficiency (e.g., HIV infection with CD4⁺ count \< 200 cells/µL, primary immunoglobulin deficiency, or post-solid-organ transplantation on maintenance immunosuppression); 9. 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; 10. Pregnancy or lactation; 11. Participation in another interventional clinical trial within 3 months prior to enrollment or ongoing at the time of study entry.

Locations (1)

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

Wuhan, China