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
Location: See all (12) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine
NOT_YET_RECRUITING
Fuzhou
Guangdong Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITING
Guangzhou
Guangzhou Medical University Affiliated Panyu Central Hospital
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
The Affiliated Qingyuan People's Hospital of Guangzhou Medical University
NOT_YET_RECRUITING
Qingyuan
Quanzhou First Hospital, Fujian
NOT_YET_RECRUITING
Quanzhou
Changhai Hospital
RECRUITING
Shanghai
Renji Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Shanghai General Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Tenth People's Hospital ,Tenth People's Hospital Affiliated to Tongji University)
NOT_YET_RECRUITING
Shanghai
Affiliated Hospital of Guangdong Medical University
NOT_YET_RECRUITING
Zhanjiang
Contact Information
Primary
Xiang yu Kong, MD
xiangyukong185@hotmail.com
13564644397
Time Frame
Start Date: 2026-04-02
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 150
Treatments
Experimental: Fecal Microbiota Transplantation
Fecal microbiota transplantation (FMT) liquid, 100 mL , administered via nasojejunal tube, once daily for 5 consecutive days, plus standard treatment.
Placebo_comparator: Placebo
Sterile saline (0.9% sodium chloride) solution, 100 mL, administered via nasojejunal tube, once daily for 5 consecutive days, plus standard treatment. Placebo is identical in appearance to FMT to maintain blinding.
Related Therapeutic Areas
Sponsors
Leads: Changhai Hospital