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Clinical Trials in China / NCT07464392
Recruiting Not applicable

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

NCT07464392 · tracked via the Priya Life Science China tracker
Sponsor
Changhai Hospital
Phase
Not applicable
Started
2026-04-02
Last updated
2026-04-14

Condition(s) studied

Acute Pancreatitis

Investigational drug(s) / intervention(s)

Fecal Microbiota TransplantationPlacebo

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.

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine Fuzhou Fujian Not Yet Recruiting
Quanzhou First Hospital, Fujian Quanzhou Fujian Not Yet Recruiting
Guangdong Hospital of Traditional Chinese Medicine Guangzhou Guangdong Not Yet Recruiting
Guangzhou Medical University Affiliated Panyu Central Hospital Guangzhou Guangdong Not Yet Recruiting
The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong Not Yet Recruiting
The Affiliated Qingyuan People's Hospital of Guangzhou Medical University Qingyuan Guangdong Not Yet Recruiting
Affiliated Hospital of Guangdong Medical University Zhanjiang Guangdong Not Yet Recruiting
Changhai Hospital Shanghai Shanghai Municipality Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Not Yet Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Not Yet Recruiting
Shanghai General Hospital Shanghai Shanghai Municipality Not Yet Recruiting
Shanghai Tenth People's Hospital ,Tenth People's Hospital Affiliated to Tongji University) Shanghai Shanghai Municipality Not Yet Recruiting

More Changhai Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07464392 on ClinicalTrials.gov ↗ ← All trials in China