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

NCT06970262 | Recruiting

• 1 other identifier: 0928-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Infection; Microbial Colonization; Food Intolerance Syndromes

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality rate

  The mortality rate within 28 days after inclusion in the study

  Within 28 days after inclusion

Secondary Outcomes (13)

• Dynamic changes in the total SOFA score

  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

  Within 24 hours before FMT intervention, and at 72 hours after last FMT administration

• Changes in intestinal microbiota diversity

  Within 24 hours before FMT intervention, and at 72 hours and 28 days after FMT initiation

• Alterations in serum metabolites

  Within 24 hours before FMT intervention, and at 72 hours after FMT initiation

• Change in the respiratory subscore of SOFA

  Within 24 hours before FMT intervention, and on days 1, 2, 3, 4, 5, 6 and 7 after FMT initiation

Study Arms (2)

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.

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.

Interventions

Fecal suspension OTHER

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.

FMT intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years, inclusive, irrespective of sex or ethnic background;
• Admission to the intensive care unit (ICU) within 48 hours;
• Anticipated ICU length of stay of ≥7 days, as determined by the attending intensivist prior to enrollment;
• Diagnosis of acute respiratory distress syndrome (ARDS) meeting the new global definition;
• Provision of written informed consent by the participant or legally authorized representative.

You may not qualify if:

• 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;
• Neutropenia defined as absolute neutrophil count \< 1.5 × 10⁹/L;
• 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);
• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, China

RECRUITING

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jiancheng Zhang

CONTACT

13554105815; zhjcheng1@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Jiancheng Zhang

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 14, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)