NCT07153809

Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis

Randomized, Double-blind Clinical Trial on the Efficacy and Safety of Gut Microbiota Transplantation (FMT) in the Treatment of Moderate to Severe Acute Pancreatitis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 exclusion criteria and divided into an intervention group (n=40) and a control group (n=40) to explore the safety and efficacy of FMT in preventing late complications of acute moderate to severe acute pancreatitis.

Conditions

• Acute Pancreatitis
• Severe Acute Pancreatitis

Interventions

Type	Name	Description
PROCEDURE	FMT	FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days.
PROCEDURE	Placebo	Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.

Timeline

• Start date: 2024-10-12
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

2 sites across 1 country: China