NCT07464392

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This multicenter, randomized, double-blind, placebo-controlled trial evaluates whether fecal microbiota transplantation (FMT) works to prevent infectious complications in patients in the late phase of moderately severe and severe acute pancreatitis. Approximately 150 eligible participants will be enrolled across 12 centers in China and randomly assigned to receive either FMT plus standard treatment or placebo plus standard treatment. The intervention is administered via nasojejunal tube once daily for five consecutive days. The study will assess infection-related outcomes, organ function, nutritional status, gastrointestinal function, gut microbiota changes, need for additional interventions or surgery, mortality, antibiotic use, and healthcare utilization. Exploratory analyses will investigate inflammatory and immune responses, and explore a predictive model based on baseline gut microbiota characteristics and clinical indicators. All analyses will follow the intention-to-treat principle, aiming to inform better treatment choices and ultimately improve patient outcomes and quality of life.

Conditions

• Acute Pancreatitis

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplantation	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.
OTHER	Placebo	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.

Timeline

• Start date: 2026-04-02
• Primary completion: 2027-07-30
• Completion: 2027-09-30
• First posted: 2026-03-11
• Last updated: 2026-04-14

Locations

12 sites across 1 country: China