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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Biological: Fecal Microbiota Transplantation; Other: Placebo

Detailed Description

This multicenter, randomized, double-blind, placebo-controlled trial evaluates whether fecal microbiota transplantation (FMT) works to prevent infectious complications in patients in the late phase of moderately severe and severe acute pancreatitis.

Approximately 150 eligible participants will be enrolled across 12 centers in China and randomly assigned to receive either FMT plus standard treatment or placebo plus standard treatment. The intervention is administered via nasojejunal tube once daily for five consecutive days.

The study will assess infection-related outcomes, organ function, nutritional status, gastrointestinal function, gut microbiota changes, need for additional interventions or surgery, mortality, antibiotic use, and healthcare utilization. Exploratory analyses will investigate inflammatory and immune responses, and explore a predictive model based on baseline gut microbiota characteristics and clinical indicators.

All analyses will follow the intention-to-treat principle, aiming to inform better treatment choices and ultimately improve patient outcomes and quality of life.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiang yu Kong, MD; Phone Number: 13564644397; Email: xiangyukong185@hotmail.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine
      • Contact: Xiaoyan Fu; Phone Number: 13859021863
    • Quanzhou, Fujian, China
      • Not yet recruiting
      • Quanzhou First Hospital, Fujian
      • Contact: Yisen Huang; Phone Number: 13905983331
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Peihong Wu; Phone Number: 13926599977
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Guangdong Hospital of Traditional Chinese Medicine
      • Contact: Cailing Zhong; Phone Number: 13580565493
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Guangzhou Medical University Affiliated Panyu Central Hospital
      • Contact: Yingying Zhao; Phone Number: 15673941051
    • Qingyuan, Guangdong, China
      • Not yet recruiting
      • The Affiliated Qingyuan People's Hospital of Guangzhou Medical University
      • Contact: Donglian Liu; Phone Number: 13425262102
    • Zhanjiang, Guangdong, China
      • Not yet recruiting
      • Affiliated Hospital of Guangdong Medical University
      • Contact: Shicai Ye; Phone Number: 13360709925
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Not yet recruiting
      • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Enqiang Mao; Phone Number: 13501747906
    • Shanghai, Shanghai Municipality, China
      • Not yet recruiting
      • Shanghai General Hospital
      • Contact: Yue Zeng; Phone Number: 18621625166
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Changhai Hospital
      • Contact: Xiangyu Kong; Phone Number: 13564644397; Email: xiangyukong185@hotmail.com
    • Shanghai, Shanghai Municipality, China
      • Not yet recruiting
      • Renji Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Keji Zhang; Phone Number: 13817592023
      • Contact: Dan Lyu; Phone Number: 13764333620
    • Shanghai, Shanghai Municipality, China
      • Not yet recruiting
      • Shanghai Tenth People's Hospital ,Tenth People's Hospital Affiliated to Tongji University)
      • Contact: Feng Liu; Phone Number: 13681973214

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fecal Microbiota Transplantation; Fecal microbiota transplantation (FMT) liquid, 100 mL , administered via nasojejunal tube, once daily for 5 consecutive days, plus standard treatment.	Biological: 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 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Infectious Complications	Proportion of participants developing any of the following infectious complications: Infected pancreatic necrosis Bacteremia Pneumonia Urosepsis Infected ascites All infections are weighted equally; multiple infections in the same patient are counted as a single endpoint.	Within 30 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Infectious Complications	Proportion of participants developing any infectious complications (as defined in the primary outcome)	Within 90 days after enrollment
Organ Failure	Incidence of organ failure assessed by Sequential Organ Failure Assessment (SOFA) score and modified Marshall score.	From enrollment to hospital discharge (up to 90 days)
Enteral Nutrition Caloric Intake	Daily enteral nutrition caloric intake assessed to evaluate adequacy of nutritional support. Reported in kcal/kg/day.	From enrollment to hospital discharge (up to 90 days)
NUTRIC Score	Nutrition Risk in Critically Ill (NUTRIC) score used to assess nutritional risk in ICU patients. Scores range from 0 to 10; higher scores indicate greater nutritional risk.	From enrollment to hospital discharge (up to 90 days)
Subjective Global Assessment (SGA)	Nutritional status assessed by Subjective Global Assessment. Patients are classified as: A (well-nourished), B (moderately malnourished), or C (severely malnourished).	Baseline, Day 30, Day 60, Day 90
Serum Nutritional Protein Markers	Serum levels of hemoglobin, albumin, and total protein measured to assess nutritional and metabolic status. Reported in g/L.	From enrollment to hospital discharge (up to 90 days)
Serum Prealbumin	Serum levels of prealbumin measured to assess nutritional and metabolic status. Reported in mg/L.	From enrollment to hospital discharge (up to 90 days)
Serum Electrolyte Levels	Serum levels of phosphorus and magnesium measured to assess electrolyte balance. Reported in mmol/L.	From enrollment to hospital discharge (up to 90 days)
Body Mass Index (BMI)	BMI calculated from measured height (meters) and weight (kilograms) to assess nutritional status. Reported in kg/m².	From enrollment to 90-day follow-up
Gastrointestinal Symptom Rating Scale (GSRS)	Gastrointestinal symptoms assessed using the simplified GSRS. Scores range from 0 to 42; higher scores indicate more severe symptoms.	From enrollment to 90-day follow-up
Incidence of Gastrointestinal Adverse Events	Daily monitoring from randomization to discharge of the following events: vomiting (≥1 episode/day), abdominal distension (assessed by daily abdominal circumference measurement), diarrhea (Bristol type 6-7 and ≥3 times/day), intestinal perforation, and abdominal bleeding. Reported in percentage of participants (%).	From enrollment to hospital discharge (up to 90 days)
Serum Total Bile Acids Level	Serum total bile acids measured to assess enterohepatic circulation and gut microbiota-mediated bile acid metabolism. Reported in μmol/L.	From enrollment to hospital discharge (up to 90 days)
Serum Diamine Oxidase (DAO) Level	Serum diamine oxidase level measured as a biomarker of intestinal mucosal barrier integrity and enterocyte damage. Reported in U/L.	From enrollment to hospital discharge (up to 90 days)
Serum Endotoxin Level	Serum endotoxin level measured to assess intestinal permeability and the degree of bacterial translocation across the gut barrier. Reported in EU/mL.	From enrollment to hospital discharge (up to 90 days)
Serum D-Lactate Level	Serum D-lactate level measured as a biomarker of intestinal mucosal permeability and bacterial overgrowth in the gastrointestinal tract. Reported in μmol/L.	From enrollment to hospital discharge (up to 90 days)
Gut Microbiota Changes	Changes in fecal microbiota composition and diversity assessed by metagenomic sequencing.	Baseline, Day 7, Day 30, Day 90
Need for Additional Interventions or Surgery	Proportion of participants requiring additional invasive interventions after FMT treatment.	From treatment initiation to 90-day follow-up
Mortality	All-cause mortality.	From enrollment to 90-day follow-up
Antibiotic Utilization	Proportion of participants receiving antibiotics and duration of antibiotic use.	From hospital admission to 90-day follow-up
Hospital Length of Stay	Duration of hospitalization (days).	From enrollment to hospital discharge (up to 90 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Total Costs	Total hospitalization costs incurred during the index admission, including costs related to medication, procedures, nursing care, and ICU stay. Reported in CNY (Chinese Yuan).	From enrollment to hospital discharge (up to 90 days)
Serum Cytokine Levels	Serum levels of IL-6, IL-8, IL-10, and TNF-α measured to assess systemic inflammatory response. Reported in pg/mL.	From enrollment to hospital discharge (up to 90 days)
Serum C-Reactive Protein (CRP) Level	Serum CRP level measured as a marker of systemic inflammation. Reported in mg/L.	From enrollment to hospital discharge (up to 90 days)
Serum Procalcitonin (PCT) Level	Serum PCT level measured as a marker of infection and inflammatory response. Reported in ng/mL.	From enrollment to hospital discharge (up to 90 days)
CD4+ and CD8+ T Cell Counts	Peripheral blood CD4+ and CD8+ T lymphocyte counts measured to assess cellular immune function.	From enrollment to hospital discharge (up to 90 days)
Immune Cell Indices	Neutrophil CD64 index and CD4+/CD8+ ratio assessed to evaluate immune activation and balance.	From enrollment to hospital discharge (up to 90 days)
Predictive Model Performance for Infectious Complications and FMT Response	Predictive performance of a model based on baseline gut microbiota characteristics and clinical parameters to identify patients at high risk for infectious complications and to predict individual response to FMT treatment, evaluated by the area under the receiver operating characteristic curve (AUC-ROC).	From enrollment to 90-day follow-up

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Study Chair: Yiqi Du, MD, The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital); Principal Investigator: Xiangyu Kong, MD, The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: March 1, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Fecal Microbiota Transplantation; Digestive System Diseases; Acute Pancreatitis; Pancreatic Diseases; Severe Acute Pancreatitis; Moderately Severe Acute Pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatitis; Pancreatic Diseases; Therapeutics; Biological Therapy; Fecal Microbiota Transplantation
• Other Study ID Numbers: KTSB20250907011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No