Acute Pancreatitis
Conditions
Keywords
Acute Pancreatitis, Moderately Severe Acute Pancreatitis, Severe Acute Pancreatitis, Fecal Microbiota Transplantation, Digestive System Diseases, Pancreatic Diseases
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALFecal Microbiota Transplantation
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.
OTHERPlacebo
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.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 * No absolute contraindications to fecal microbiota transplantation * Voluntarily sign the written informed consent form
Exclusion criteria
* 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 * Pre-existing chronic organ dysfunction (heart, lung, liver, kidney, or hematologic system) prior to admission * Multiple organ dysfunction syndrome (MODS) with a confirmed duration exceeding 2 weeks * Active malignancy * Autoimmune disease or immunocompromised status (including solid organ or bone marrow transplantation, AIDS, long-term use of immunosuppressants or hormones) * Congenital or acquired immunodeficiency * Pregnancy or breastfeeding * Severe mental disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Infectious Complications | Within 30 days after enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Infectious Complications | Within 90 days after enrollment | Proportion of participants developing any infectious complications (as defined in the primary outcome) |
| Organ Failure | From enrollment to hospital discharge (up to 90 days) | Incidence of organ failure assessed by Sequential Organ Failure Assessment (SOFA) score and modified Marshall score. |
| Enteral Nutrition Caloric Intake | From enrollment to hospital discharge (up to 90 days) | Daily enteral nutrition caloric intake assessed to evaluate adequacy of nutritional support. Reported in kcal/kg/day. |
| NUTRIC Score | From enrollment to hospital discharge (up to 90 days) | 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. |
| Subjective Global Assessment (SGA) | Baseline, Day 30, Day 60, Day 90 | Nutritional status assessed by Subjective Global Assessment. Patients are classified as: A (well-nourished), B (moderately malnourished), or C (severely malnourished). |
| Serum Nutritional Protein Markers | From enrollment to hospital discharge (up to 90 days) | Serum levels of hemoglobin, albumin, and total protein measured to assess nutritional and metabolic status. Reported in g/L. |
| Serum Prealbumin | From enrollment to hospital discharge (up to 90 days) | Serum levels of prealbumin measured to assess nutritional and metabolic status. Reported in mg/L. |
| Serum Electrolyte Levels | From enrollment to hospital discharge (up to 90 days) | Serum levels of phosphorus and magnesium measured to assess electrolyte balance. Reported in mmol/L. |
| Body Mass Index (BMI) | From enrollment to 90-day follow-up | BMI calculated from measured height (meters) and weight (kilograms) to assess nutritional status. Reported in kg/m². |
| Gastrointestinal Symptom Rating Scale (GSRS) | From enrollment to 90-day follow-up | Gastrointestinal symptoms assessed using the simplified GSRS. Scores range from 0 to 42; higher scores indicate more severe symptoms. |
| Incidence of Gastrointestinal Adverse Events | From enrollment to hospital discharge (up to 90 days) | 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 Level | From enrollment to hospital discharge (up to 90 days) | Serum total bile acids measured to assess enterohepatic circulation and gut microbiota-mediated bile acid metabolism. Reported in μmol/L. |
| Serum Diamine Oxidase (DAO) Level | From enrollment to hospital discharge (up to 90 days) | Serum diamine oxidase level measured as a biomarker of intestinal mucosal barrier integrity and enterocyte damage. Reported in U/L. |
| Serum Endotoxin Level | From enrollment to hospital discharge (up to 90 days) | 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 | From enrollment to hospital discharge (up to 90 days) | Serum D-lactate level measured as a biomarker of intestinal mucosal permeability and bacterial overgrowth in the gastrointestinal tract. Reported in μmol/L. |
| Gut Microbiota Changes | Baseline, Day 7, Day 30, Day 90 | Changes in fecal microbiota composition and diversity assessed by metagenomic sequencing. |
| Need for Additional Interventions or Surgery | From treatment initiation to 90-day follow-up | Proportion of participants requiring additional invasive interventions after FMT treatment. |
| Mortality | From enrollment to 90-day follow-up | All-cause mortality. |
| Antibiotic Utilization | From hospital admission to 90-day follow-up | Proportion of participants receiving antibiotics and duration of antibiotic use. |
| Hospital Length of Stay | From enrollment to hospital discharge (up to 90 days) | Duration of hospitalization (days). |
Countries
China
Contacts
CONTACTXiang yu Kong, MD
STUDY_CHAIRYiqi Du, MD
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
PRINCIPAL_INVESTIGATORXiangyu Kong, MD
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
Outcome results
None listed