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FMT for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis

NCT07464392 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Yiqi Du, MD · The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)

  • Xiangyu Kong, MD · The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-02
Primary Completion
2027-07-30
Completion
2027-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07464392 on ClinicalTrials.gov