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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Acute Pancreatitis

In brief

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.

Key facts

Study ID

NCT07464392

Run by

Changhai Hospital

People needed

150

Starts

2026-04-02

Expected to finish

2027-09-30

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Changhai Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Quanzhou First Hospital, Fujian — Quanzhou, Fujian, China
• Guangdong Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China
• Guangzhou Medical University Affiliated Panyu Central Hospital — Guangzhou, Guangdong, China
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• The Affiliated Qingyuan People's Hospital of Guangzhou Medical University — Qingyuan, Guangdong, China
• Affiliated Hospital of Guangdong Medical University — Zhanjiang, Guangdong, China
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
• Shanghai General Hospital — Shanghai, Shanghai Municipality, China
• The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine — Fuzhou, Fujian, China
• Shanghai Tenth People's Hospital ,Tenth People's Hospital Affiliated to Tongji University) — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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