Status:
RECRUITING
Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis
Lead Sponsor:
Changhai Hospital
Conditions:
Acute Pancreatitis
Severe Acute Pancreatitis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07153809
Start Date
October 12 2024
End Date
December 31 2026
Last Update
September 4 2025
Active Locations (2)
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1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
2
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433