FMT for Feeding Intolerance Due to Gastrointestinal Dysfunction in Critically Ill Patients

NCT07640633 · tracked via the Priya Life Science China tracker

Sponsor

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

Phase

Not applicable

Started

2026-10-01

Last updated

2026-09-16

Condition(s) studied

Feeding IntoleranceGastrointestinal DysfunctionCritically Ill Intensive Care Unit Patients

Investigational drug(s) / intervention(s)

Fecal microbiota transplantation (FMT)

Fecal microbiota transplantation (FMT): Patients received FMT via a nasojejunal tube in addition to standard ICU care. Specifically, 50-100 mL of intestinal microbiota suspension was administered daily via the nasojejunal tube between 11:00 and 13:00 for three consecutive days.

Study summary

Critically ill patients admitted to the intensive care unit (ICU) frequently present with gastrointestinal dysfunction and are at elevated risk of malnutrition. Gastrointestinal dysfunction is correlated with adverse clinical outcomes, including prolonged mechanical ventilation duration, extended ICU length of stay, and increased 90-day mortality.

In critically ill ICU patients, severe gut microbiota dysbiosis and intestinal barrier impairment may occur due to the burden of primary critical illnesses, as well as the administration of proton pump inhibitors and antibiotics. This cascade contributes to a high prevalence of gastrointestinal dysfunction, alongside profound gut-derived systemic inflammatory responses and organ damage. Given the pivotal role of gut microbiota in maintaining intestinal homeostasis, fecal microbiota transplantation (FMT) holds promise as a novel therapeutic strategy for enteral feeding intolerance secondary to gastrointestinal dysfunction in critically ill ICU patients.

This study intends to deliver FMT via a nasojejunal tube to critically ill patients with gastrointestinal dysfunction admitted to the ICU. Its objectives are to evaluate the intervention's effects on gastrointestinal function recovery and the alleviation of enteral feeding intolerance, while also assessing its impacts on intestinal barrier function, gut microbiota composition and metabolic profiles, serum metabolite signatures, immune-inflammatory responses (including lymphocyte subsets, cytokines, C-reactive protein, and procalcitonin), ICU delirium, ICU sleep quality, and clinical outcomes (encompassing ICU mortality, in-hospital mortality, 28-day all-cause mortality, 90-day all-cause mortality, 90-day readmission rate, and 90-day incidence of secondary infections).

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: 1. Aged 18 to 70 years inclusive, regardless of ethnicity or gender; 2. Female participants are either non-fertile (i.e., physiologically incapable of pregnancy, including women with ≥2 years of menopause) or have no pregnancy plans; 3. Have been admitted to the ICU for ≥24 hours; 4. Expected ICU stay ≥7 days after study enrollment; 5. Screened positive for ≥1 manifestation of gastrointestinal dysfunction (intra-abdominal hypertension \[IAH\], massive gastric retention, diarrhea, lower gastrointestinal paralysis, bowel dilatation); enteral nutrition is then implemented under the guidance of the enteral feeding intolerance (FI) score, and participants with persistent FI after a 3-day trial are formally enrolled; 6. Participants can actively cooperate or passively complete relevant examinations and follow-up procedures; 7. Have signed a written informed consent form. Exclusion Criteria: 1. Severe systemic infection in the early resuscitation phase, with hemodynamic instability, insufficient tissue perfusion, or severe fluid-electrolyte and acid-base imbalances; 2. Patients assessed by clinicians as having a high risk of death within 5 days, or those with restricted treatment decisions; 3. Active gastrointestinal bleeding, perforation, or other conditions with severe intestinal barrier impairment; 4. Patients unable to tolerate enteral nutrition meeting 50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stenosis, massive gastrointestinal bleeding, or high-output enterocutaneous fistula; 5. Planned or recent abdominal surgery (within 14 days prior to enrollment); 6. Current diagnosis of fulminant colitis or toxic megacolon; 7. Neutropenia (neutrophil count \< 1500 cells/µL); 8. Patients with congenital or acquired immunodeficiency disorders; 9. Recent receipt of high-risk immunosuppressive or cytotoxic agents, e.g., rituximab, doxorubicin, or medium-to-high-dose corticosteroids (≥ 20 mg/day prednisone equivalent) for a duration of \> 4 weeks; 10. Pregnant or lactating women; 11. Participation in another clinical trial as a subject at the time of enrollment or within 3 months prior to enrollment; 12. Doubtful validity of informed consent: subjects with mental illness, intellectual disability, poor motivation, or other factors that restrict the validity of informed consent for participation in this study.

Primary outcome measure(s)

Enteral nutrition FI improvement rate — 24, 48, 72, 96, and 120 hours after study enrollment

Trial sites (1)

Facility	City	Region	Status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China

Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Peripheral Neuropathic Pain. Recruiting

Clinical Effectiveness of CEM in Diagnosis of Additional Findings at Preoperative Breast Magnetic Resonance Imaging Starting soon

Efficacy and Safety of Retlirafusp Alfa Plus Bevacizumab and Chemotherapy With or Without Short-Course Radiotherapy in Patients With CRCLM Recruiting

Deep Learning-Based Multidimensional Body Composition Mapping for Outcome Prediction in HCC Patients Undergoing TACE Recruiting

Dalpiciclib Combined With Aromatase Inhibitors and Olmesartan as the First-line Treatment for HR+/HER2- Advanced Breast Cancer Recruiting

Other trials for the same condition

Blood DdPCR for Early Identification and Dynamic Surveillance of Pathogenic Bacteria in ICU Septic Patients: a Single-centre, Prospective, Observational Study Recruiting

Remimazolam vs Propofol for Long-Term Sedation in Mechanically Ventilated ICU Patients Starting soon

Effect of HFNC on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients Recruiting

Efficacy of Fuzheng Tongfu Jiedu Prescription for Treating Gastrointestinal Dysfunction Associated With Sepsis Starting soon

Clinical Study on the Treatment of Gastrointestinal Dysfunction After Knee Joint Surgery Under General Anesthesia With Floating Needle Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07640633 on ClinicalTrials.gov ↗ ← All trials in China