Actively Recruiting
Randomized, Double-blind Clinical Trial on the Efficacy and Safety of Gut Microbiota Transplantation (FMT) in the Treatment of Moderate to Severe Acute Pancreatitis
Led by Changhai Hospital · Updated on 2025-09-04
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of fecal microbiota transplantation (FMT) in patients with moderate to severe acute pancreatitis. This randomized, double-blind, placebo-controlled trial aims to prevent late complications of this condition by comparing FMT with a placebo treatment. The study is conducted at a single center and involves 80 patients who meet specific diagnosis and health criteria. Participants are randomly assigned to one of two groups: one receives a daily injection of FMT bacterial solution through a nasojejunal nutrition tube for five days, while the other group receives a placebo injection of physiological saline via the same method and schedule. Before FMT, patients undergo intestinal preparation, and the treatment starts once intestinal function is restored and inflammatory signs improve. Use of probiotics, antibiotics, and other drugs affecting gut microbiota is restricted during the study. Throughout the trial, patients undergo thorough evaluations before, during, and after treatment, including safety and efficacy assessments. Researchers monitor pancreatic infectious complications over approximately one year, along with changes in pancreatitis severity scores, gut microbiome, gut barrier health, and inflammatory markers up to three months. The study involves careful observation to understand how FMT impacts recovery and complications in acute pancreatitis patients.
CONDITIONS
Brief 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 function may include recoverable organ failure within 48 hours
- Disease stage about 2 weeks after onset with pancreatic fluid accumulation and improved pancreatitis severity score
- Enteral nutrition tube in place
- No absolute contraindications for gut microbiota transplantation
- Voluntarily signed informed consent form
- Abdominal pressure less than 12 mmHg
- Presence of spontaneous defecation or exhaust
- Significant improvement in abdominal distension compared to before
You will not qualify if you...
- Serious complications like gastrointestinal bleeding or intestinal fistula
- Pregnant or lactating women
- Failure to sign informed consent
- Chronic organ dysfunction in heart, lungs, liver, kidneys, or blood system before admission
- Incurable malignant tumors
- Autoimmune diseases or immunosuppression status
- Inability to meet 50% of calorie requirements due to enteral nutrition intolerance
- Presence of systemic inflammatory response syndrome (SIRS)
- Need for broad-spectrum antibiotics for extraintestinal organ infections
- Congenital or acquired immunodeficiency
- Severe mental disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive either FMT bacterial solution or a placebo through a nasojejunal nutrition tube once a day for five days following intestinal preparation and restoration of intestinal function.
5 daily visits (in-person)
Duration - Up to 1 year
Participants are monitored for safety and efficacy during treatment, immediately after treatment, and for one week following treatment, with long-term observation for up to 1 year for complications and changes in health status.
Visits during treatment, after treatment, and one week post-treatment; additional assessments over the year as needed
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
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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