Fecal microbiota transplant to prevent infections after late-phase severe acute pancreatitis

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

This trial will test whether giving healthy donor gut bacteria (fecal microbiota transplantation) through a feeding tube in the late phase of moderately severe or severe acute pancreatitis can prevent infectious complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Locations: 12 sites (Fuzhou, Fujian and 11 other locations)
• Trial ID: NCT07464392 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled trial enrolling about 150 participants across centers in China who have moderately severe or severe acute pancreatitis in the late phase (15–21 days). Participants are randomized to receive either fecal microbiota transplantation (FMT) or placebo via a nasojejunal tube once daily for five consecutive days in addition to standard care. The study will track infection-related outcomes, organ and gastrointestinal function, nutritional status, antibiotic use, mortality, healthcare utilization, and changes in gut microbiota. Exploratory analyses will examine inflammatory and immune responses and develop a predictive model using baseline microbiota and clinical indicators, with all analyses on an intention-to-treat basis.

Who should consider this trial

Good fit: Adults 18–75 years with moderately severe or severe acute pancreatitis (CTSI >4), 15–21 days from symptom onset, who already have a nasojejunal tube and no contraindications to FMT may be eligible.

Not a fit: Patients with ongoing severe systemic or extra‑intestinal organ infections requiring broad‑spectrum antibiotics, major intestinal complications (obstruction, perforation, active bleeding), inability to tolerate enteral nutrition, or significant pre‑existing organ dysfunction are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the intervention could reduce infectious complications, lower antibiotic use, and improve recovery and quality of life after severe acute pancreatitis.

How similar studies have performed: FMT is well established for recurrent C. difficile and has shown promise in other gut disorders, but using FMT to prevent infections in late‑phase severe acute pancreatitis is a relatively novel approach with limited prior clinical evidence.

Eligibility criteria

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

Where this trial is running

Fuzhou, Fujian and 11 other locations

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

Study contacts

• Principal investigator: Xiangyu Kong, MD — The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
• Study coordinator: Xiang yu Kong, MD

Conditions Acute Pancreatitis; Moderately Severe Acute Pancreatitis; Severe Acute Pancreatitis; Fecal Microbiota Transplantation; Digestive System Diseases; Pancreatic Diseases