Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07464392

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

Led by Changhai Hospital · Updated on 2026-04-14

150

Participants Needed

12

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Diagnosed with moderately severe or severe acute pancreatitis according to the Revised Atlanta Classification 2012 and a CT severity index score greater than 4
  • Disease duration of 15 to 21 days
  • Have a nasojejunal tube in place
  • No absolute contraindications to fecal microbiota transplantation
  • Voluntarily signed the written informed consent form
Not Eligible

You will not qualify if you...

  • Severe systemic infection at the time of enrollment
  • Extra-intestinal organ infection requiring broad-spectrum antibiotics
  • Intestinal obstruction, active gastrointestinal bleeding, intestinal perforation, fulminant colitis, or toxic megacolon
  • Unable to tolerate enteral nutrition meeting 50% of caloric needs due to severe diarrhea, fibrotic intestinal stricture, severe gastrointestinal bleeding, or high-output intestinal fistula
  • Pre-existing chronic organ dysfunction (heart, lung, liver, kidney, or blood system) before admission
  • Multiple organ dysfunction syndrome lasting more than 2 weeks
  • Active cancer
  • Autoimmune disease or immunocompromised status including organ transplant, AIDS, or long-term immunosuppressant or hormone use
  • Congenital or acquired immunodeficiency
  • Pregnancy or breastfeeding
  • Severe mental disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine

Fuzhou, Fujian, China

Not Yet Recruiting

2

Quanzhou First Hospital, Fujian

Quanzhou, Fujian, China

Not Yet Recruiting

3

Guangdong Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Not Yet Recruiting

4

Guangzhou Medical University Affiliated Panyu Central Hospital

Guangzhou, Guangdong, China

Not Yet Recruiting

5

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Not Yet Recruiting

6

The Affiliated Qingyuan People's Hospital of Guangzhou Medical University

Qingyuan, Guangdong, China

Not Yet Recruiting

7

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Not Yet Recruiting

8

Changhai Hospital

Shanghai, Shanghai Municipality, China

Actively Recruiting

9

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Not Yet Recruiting

10

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Not Yet Recruiting

11

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Not Yet Recruiting

12

Shanghai Tenth People's Hospital ,Tenth People's Hospital Affiliated to Tongji University)

Shanghai, Shanghai Municipality, China

Not Yet Recruiting

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Research Team

X

Xiang yu Kong, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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