The goal of this clinical trial is to learn whether fecal microbiota transplantation (FMT) works to prevent infections complications in patients in the late phase of moderately severe or severe acute pancreatitis.
Age between 18 and 75 years
Diagnosed with moderately severe acute pancreatitis (MSAP) or severe acute pancreatitis (SAP) according to the Revised Atlanta Classification 2012, with CT severity index (CTSI) score > 4
Disease duration of 15 to 21 days
Already have a nasojejunal tube in place
Concurrent severe systemic infection
Concurrent extra-intestinal organ infection requiring intervention with broad-spectrum antibiotics
Intestinal obstruction, active gastrointestinal bleeding, intestinal perforation, fulminant colitis, or toxic megacolon
Unable to tolerate enteral nutrition meeting 50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stricture, severe gastrointestinal bleeding, or high-output intestinal fistula
Parallel
Fecal Microbiota Transplantation
Biological/VaccineFecal microbiota transplantation (FMT) liquid is a biological intervention consisting of processed and standardized human fecal microbiota from healthy donors, suspended in sterile saline with cryoprotectant.
Placebo
Other interventionSterile saline (0.9% sodium chloride) solution, packaged identically to FMT liquid with opaque materials to maintain blinding, contains no active components and serves as a placebo control.
Incidence of Infectious Complications
Proportion of participants developing any of the following infectious complications: Infected pancreatic necrosis Bacteremia Pneumonia Urosepsis Infected ascites All infections are weighted equally; multiple infections in the same patient are counted as a single endpoint.
Incidence of Infectious Complications
Proportion of participants developing any infectious complications (as defined in the primary outcome)
Organ Failure
Incidence of organ failure assessed by Sequential Organ Failure Assessment (SOFA) score and modified Marshall score.
Enteral Nutrition Caloric Intake
Daily enteral nutrition caloric intake assessed to evaluate adequacy of nutritional support. Reported in kcal/kg/day.
NUTRIC Score
Nutrition Risk in Critically Ill (NUTRIC) score used to assess nutritional risk in ICU patients. Scores range from 0 to 10; higher scores indicate greater nutritional risk.
Hospital Total Costs
Total hospitalization costs incurred during the index admission, including costs related to medication, procedures, nursing care, and ICU stay. Reported in CNY (Chinese Yuan).
Serum Cytokine Levels
Serum levels of IL-6, IL-8, IL-10, and TNF-α measured to assess systemic inflammatory response. Reported in pg/mL.
Serum C-Reactive Protein (CRP) Level
Serum CRP level measured as a marker of systemic inflammation. Reported in mg/L.
Serum Procalcitonin (PCT) Level
Serum PCT level measured as a marker of infection and inflammatory response. Reported in ng/mL.
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