FMT for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis

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.

Proportion of participants developing any infectious complications (as defined in the primary outcome)

Incidence of organ failure assessed by Sequential Organ Failure Assessment (SOFA) score and modified Marshall score.

Daily enteral nutrition caloric intake assessed to evaluate adequacy of nutritional support. Reported in kcal/kg/day.

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.

Nutritional status assessed by Subjective Global Assessment. Patients are classified as: A (well-nourished), B (moderately malnourished), or C (severely malnourished).

Serum levels of hemoglobin, albumin, and total protein measured to assess nutritional and metabolic status. Reported in g/L.

Serum levels of prealbumin measured to assess nutritional and metabolic status. Reported in mg/L.

Serum levels of phosphorus and magnesium measured to assess electrolyte balance. Reported in mmol/L.

BMI calculated from measured height (meters) and weight (kilograms) to assess nutritional status. Reported in kg/m².

Gastrointestinal symptoms assessed using the simplified GSRS. Scores range from 0 to 42; higher scores indicate more severe symptoms.

Daily monitoring from randomization to discharge of the following events: vomiting (≥1 episode/day), abdominal distension (assessed by daily abdominal circumference measurement), diarrhea (Bristol type 6-7 and ≥3 times/day), intestinal perforation, and abdominal bleeding. Reported in percentage of participants (%).

Serum total bile acids measured to assess enterohepatic circulation and gut microbiota-mediated bile acid metabolism. Reported in μmol/L.

Serum diamine oxidase level measured as a biomarker of intestinal mucosal barrier integrity and enterocyte damage. Reported in U/L.

Serum endotoxin level measured to assess intestinal permeability and the degree of bacterial translocation across the gut barrier. Reported in EU/mL.

Serum D-lactate level measured as a biomarker of intestinal mucosal permeability and bacterial overgrowth in the gastrointestinal tract. Reported in μmol/L.

Changes in fecal microbiota composition and diversity assessed by metagenomic sequencing.

Proportion of participants requiring additional invasive interventions after FMT treatment.

All-cause mortality.

Proportion of participants receiving antibiotics and duration of antibiotic use.

Duration of hospitalization (days).

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 levels of IL-6, IL-8, IL-10, and TNF-α measured to assess systemic inflammatory response. Reported in pg/mL.

Serum CRP level measured as a marker of systemic inflammation. Reported in mg/L.

Serum PCT level measured as a marker of infection and inflammatory response. Reported in ng/mL.

Peripheral blood CD4+ and CD8+ T lymphocyte counts measured to assess cellular immune function.

Neutrophil CD64 index and CD4+/CD8+ ratio assessed to evaluate immune activation and balance.

Predictive performance of a model based on baseline gut microbiota characteristics and clinical parameters to identify patients at high risk for infectious complications and to predict individual response to FMT treatment, evaluated by the area under the receiver operating characteristic curve (AUC-ROC).