Actively Recruiting
Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis
Led by Changhai Hospital · Updated on 2025-09-04
80
Participants Needed
2
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old
- Diagnosis meets criteria for severe acute pancreatitis
- Organ failure or systemic complications recoverable within 48 hours
- Approximately 2 weeks after disease onset with significant improvement in CTSI score (grade II)
- Enteral nutrition tube in place
- No absolute contraindications for gut microbiota transplantation
- Voluntarily signed written informed consent
- Abdominal pressure less than 12 mmHg
- Presence of spontaneous defecation or gas passage
- Significant improvement in abdominal distension compared to before
You will not qualify if you...
- Serious complications such as gastrointestinal bleeding or intestinal fistula
- Pregnant or lactating women
- Failure to sign informed consent form
- Chronic organ dysfunction prior to admission in heart, lungs, liver, kidneys, or blood system
- Incurable malignant tumors
- Autoimmune diseases
- Immunosuppression status (including transplant history, AIDS, long-term immunosuppressant or hormone use)
- Enteral nutrition intolerance due to severe diarrhea, intestinal stenosis, edema, or fistula
- Systemic infection meeting criteria for systemic inflammatory response syndrome (SIRS)
- Need for broad-spectrum antibiotics for extraintestinal infections
- Congenital or acquired immunodeficiency
- Severe mental disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
2
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
K
Kong Xiang yu, associate professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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