FMT: FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days.
Placebo: Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Pancreatic infectious complications — through study completion, an average of 1 year Infectious pancreatic necrosis, sepsis, and pancreatic fistula. Infectious pancreatic necrosis: (1) Imaging suggests the formation of gas at the site of necrosis aggregation; (2) Gram staining or culture positivity of necrotic specimens obtained through percutaneous fine needle aspiration (FNAC); (3) Clinically suspected infection symptoms. However, due to the high false positive rate, routine FNAC examination is not recommended.
Sepsis: (1) Two blood cultures (or bone marrow cultures) are positive for the same pathogen. (2) Systemic inflammatory response syndrome (SIRS) occurs.
Pancreatic fistula: (1) History of acute necrotizing pancreatitis attacks; (2) Imaging supports the diagnosis of pancreatic fistula.
Measurement: Yes/No (incidence rate)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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