Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis

Randomized, Double-blind Clinical Trial on the Efficacy and Safety of Gut Microbiota Transplantation (FMT) in the Treatment of Moderate to Severe Acute Pancreatitis

This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT in patients with moderate to severe acute pancreatitis.

This study is a single center, randomized controlled trial. After the start of the study, 80 patients with acute moderate to severe acute pancreatitis were randomly selected according to inclusion and exclusion criteria and divided into an intervention group (n=40) and a control group (n=40) to explore the safety and efficacy of FMT in preventing late complications of acute moderate to severe acute pancreatitis.

Inclusion Criteria:

Age: 18-70 years old Diagnosis: Meets the diagnostic criteria for severe acute pancreatitis (SAP)

• Organ function: There may be organ failure and systemic complications that can be recovered within 48 hours
• Stage of the disease: Approximately 2 weeks after onset (non acute phase), accompanied by accumulation of pancreatic fluid volume, and significant improvement in CTSI score compared to before (grade II)
• Nutritional support: Enteral nutrition tube has been left in place Feasibility of transplantation: No absolute contraindications for gut microbiota transplantation
• Informed Consent: Voluntarily sign a written informed consent form
• Gastrointestinal status:

Abdominal pressure (bladder pressure measurement)<12mmHg ◦ Existence of spontaneous defecation/exhaust Significant improvement in abdominal distension compared to before

Exclusion Criteria:

Serious complications: combined gastrointestinal bleeding or intestinal fistula

• Special population: Pregnant or lactating women
• Informed refusal: Failure to sign informed consent form
• Basic organ dysfunction: Prior to admission, there were chronic organ dysfunction in the heart, lungs, liver, kidneys, or blood system Malignant tumor: Suffering from incurable malignant tumors
• Immune abnormalities:

Autoimmune diseases

◦ Immunosuppression status (solid organ/bone marrow transplantation history, AIDS, long-term use of immunosuppressants/hormones)

• Enteral nutrition intolerance: unable to meet 50% of calorie requirements due to severe diarrhea, fibrotic intestinal stenosis, severe gastrointestinal edema, high flow intestinal fistula, etc
• Systemic infection: meets the diagnostic criteria for systemic inflammatory response syndrome (SIRS)
• Antibiotic dependence: broad-spectrum antibiotic intervention is required for combined extraintestinal organ infections
• Immunodeficiency: Congenital or acquired immunodeficiency
• Mental illness: severe mental disorders