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.
This multicenter, randomized, double-blind, placebo-controlled trial evaluates whether fecal microbiota transplantation (FMT) works to prevent infectious complications in patients in the late phase of moderately severe and severe acute pancreatitis. Approximately 150 eligible participants will be enrolled across 12 centers in China and randomly assigned to receive either FMT plus standard treatment or placebo plus standard treatment. The intervention is administered via nasojejunal tube once daily for five consecutive days. The study will assess infection-related outcomes, organ function, nutritional status, gastrointestinal function, gut microbiota changes, need for additional interventions or surgery, mortality, antibiotic use, and healthcare utilization. Exploratory analyses will investigate inflammatory and immune responses, and explore a predictive model based on baseline gut microbiota characteristics and clinical indicators. All analyses will follow the intention-to-treat principle, aiming to inform better treatment choices and ultimately improve patient outcomes and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
150
Fecal 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.
Sterile 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.
The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine
Fuzhou, Fujian, China
NOT_YET_RECRUITINGQuanzhou First Hospital, Fujian
Quanzhou, Fujian, China
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.
Time frame: Within 30 days after enrollment
Incidence of Infectious Complications
Proportion of participants developing any infectious complications (as defined in the primary outcome)
Time frame: Within 90 days after enrollment
Organ Failure
Incidence of organ failure assessed by Sequential Organ Failure Assessment (SOFA) score and modified Marshall score.
Time frame: From enrollment to hospital discharge (up to 90 days)
Enteral Nutrition Caloric Intake
Daily enteral nutrition caloric intake assessed to evaluate adequacy of nutritional support. Reported in kcal/kg/day.
Time frame: From enrollment to hospital discharge (up to 90 days)
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.
Time frame: From enrollment to hospital discharge (up to 90 days)
Subjective Global Assessment (SGA)
Nutritional status assessed by Subjective Global Assessment. Patients are classified as: A (well-nourished), B (moderately malnourished), or C (severely malnourished).
Time frame: Baseline, Day 30, Day 60, Day 90
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Guangdong Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGGuangzhou Medical University Affiliated Panyu Central Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe Affiliated Qingyuan People's Hospital of Guangzhou Medical University
Qingyuan, Guangdong, China
NOT_YET_RECRUITINGAffiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
NOT_YET_RECRUITINGChanghai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGRenji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGRuijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITING...and 2 more locations
Serum Nutritional Protein Markers
Serum levels of hemoglobin, albumin, and total protein measured to assess nutritional and metabolic status. Reported in g/L.
Time frame: From enrollment to hospital discharge (up to 90 days)
Serum Prealbumin
Serum levels of prealbumin measured to assess nutritional and metabolic status. Reported in mg/L.
Time frame: From enrollment to hospital discharge (up to 90 days)
Serum Electrolyte Levels
Serum levels of phosphorus and magnesium measured to assess electrolyte balance. Reported in mmol/L.
Time frame: From enrollment to hospital discharge (up to 90 days)
Body Mass Index (BMI)
BMI calculated from measured height (meters) and weight (kilograms) to assess nutritional status. Reported in kg/m².
Time frame: From enrollment to 90-day follow-up
Gastrointestinal Symptom Rating Scale (GSRS)
Gastrointestinal symptoms assessed using the simplified GSRS. Scores range from 0 to 42; higher scores indicate more severe symptoms.
Time frame: From enrollment to 90-day follow-up
Incidence of Gastrointestinal Adverse Events
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 (%).
Time frame: From enrollment to hospital discharge (up to 90 days)
Serum Total Bile Acids Level
Serum total bile acids measured to assess enterohepatic circulation and gut microbiota-mediated bile acid metabolism. Reported in μmol/L.
Time frame: From enrollment to hospital discharge (up to 90 days)
Serum Diamine Oxidase (DAO) Level
Serum diamine oxidase level measured as a biomarker of intestinal mucosal barrier integrity and enterocyte damage. Reported in U/L.
Time frame: From enrollment to hospital discharge (up to 90 days)
Serum Endotoxin Level
Serum endotoxin level measured to assess intestinal permeability and the degree of bacterial translocation across the gut barrier. Reported in EU/mL.
Time frame: From enrollment to hospital discharge (up to 90 days)
Serum D-Lactate Level
Serum D-lactate level measured as a biomarker of intestinal mucosal permeability and bacterial overgrowth in the gastrointestinal tract. Reported in μmol/L.
Time frame: From enrollment to hospital discharge (up to 90 days)
Gut Microbiota Changes
Changes in fecal microbiota composition and diversity assessed by metagenomic sequencing.
Time frame: Baseline, Day 7, Day 30, Day 90
Need for Additional Interventions or Surgery
Proportion of participants requiring additional invasive interventions after FMT treatment.
Time frame: From treatment initiation to 90-day follow-up
Mortality
All-cause mortality.
Time frame: From enrollment to 90-day follow-up
Antibiotic Utilization
Proportion of participants receiving antibiotics and duration of antibiotic use.
Time frame: From hospital admission to 90-day follow-up
Hospital Length of Stay
Duration of hospitalization (days).
Time frame: From enrollment to hospital discharge (up to 90 days)