FMT for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis
Fecal Microbiota Transplantation for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis: A Multicenter, Randomized, Double-Blind Clinical Trial
Changhai Hospital
150 participants
Apr 2, 2026
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn whether fecal microbiota transplantation (FMT) works to prevent infections complications in patients in the late phase of moderately severe or severe acute pancreatitis.
Eligibility
Inclusion Criteria6
- Age between 18 and 75 years
- Diagnosed with moderately severe acute pancreatitis (MSAP) or severe acute pancreatitis (SAP) according to the Revised Atlanta Classification 2012, with CT severity index (CTSI) score > 4
- Disease duration of 15 to 21 days
- Already have a nasojejunal tube in place
- No absolute contraindications to fecal microbiota transplantation
- Voluntarily sign the written informed consent form
Exclusion Criteria11
- Concurrent severe systemic infection
- Concurrent extra-intestinal organ infection requiring intervention with broad-spectrum antibiotics
- Intestinal obstruction, active gastrointestinal bleeding, intestinal perforation, fulminant colitis, or toxic megacolon
- Unable to tolerate enteral nutrition meeting 50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stricture, severe gastrointestinal bleeding, or high-output intestinal fistula
- Pre-existing chronic organ dysfunction (heart, lung, liver, kidney, or hematologic system) prior to admission
- Multiple organ dysfunction syndrome (MODS) with a confirmed duration exceeding 2 weeks
- Active malignancy
- Autoimmune disease or immunocompromised status (including solid organ or bone marrow transplantation, AIDS, long-term use of immunosuppressants or hormones)
- Congenital or acquired immunodeficiency
- Pregnancy or breastfeeding
- Severe mental disorder
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Interventions
Fecal microbiota transplantation (FMT) liquid is a biological intervention consisting of processed and standardized human fecal microbiota from healthy donors, suspended in sterile saline with cryoprotectant.
Sterile saline (0.9% sodium chloride) solution, packaged identically to FMT liquid with opaque materials to maintain blinding, contains no active components and serves as a placebo control.
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT07464392