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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Enteral nutrition FI improvement rate
Time frame: 24, 48, 72, 96, and 120 hours after study enrollment
Gut microbiota composition as well as α and β diversity measured from rectal swabs by 16S rRNA gene sequencing
Time frame: 24-0 hours and 120 hours after study enrollment
Fecal metabolite profile (by untargeted LC-MS) from rectal swabs
Time frame: 24-0 hours and 120 hours after study enrollment
Serum metabolite profile (by untargeted LC-MS)
Time frame: 24-0 hours and 120 hours after study enrollment
Serum level of citrulline
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
APACHE II score
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
SOFA score
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Cumulative intravenous dose of vasopressor agents (including norepinephrine, epinephrine, dobutamine, etc.)
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Serum level of C-reactive protein
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Serum level of procalcitonin
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Peripheral blood level of cytokines (including IL-6, IL-17, TNF-α, IL-10, IL-1β, etc.)
Time frame: 0 and 120 hours after study enrollment
Peripheral blood lymphocyte subsets (including CD4+ T, CD8+ T, B lymphocytes, NK cells, etc.)
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
ICU mortality
Time frame: Within 28 days after study enrollment
In-hospital mortality
Time frame: Within 60 days after study enrollment
28-day all-cause mortality
Time frame: Within 28 days after study enrollment
90-day all-cause mortality
Time frame: Within 90 days after study enrollment
90-day readmission rate
Time frame: Within 90 days after study enrollment
90-day secondary infection rate
Time frame: Within 90 days after study enrollment
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