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

Official title

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

Overview

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.

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Incidence of Infectious Complications [Time frame: Within 30 days after enrollment]

Secondary outcome measures (12)

• Incidence of Infectious Complications [Time frame: Within 90 days after enrollment]
• Organ Failure [Time frame: From enrollment to hospital discharge (up to 90 days)]
• Enteral Nutrition Caloric Intake [Time frame: From enrollment to hospital discharge (up to 90 days)]
• NUTRIC Score [Time frame: From enrollment to hospital discharge (up to 90 days)]
• Subjective Global Assessment (SGA) [Time frame: Baseline, Day 30, Day 60, Day 90]
• Serum Nutritional Protein Markers [Time frame: From enrollment to hospital discharge (up to 90 days)]
• Serum Prealbumin [Time frame: From enrollment to hospital discharge (up to 90 days)]
• Serum Electrolyte Levels [Time frame: From enrollment to hospital discharge (up to 90 days)]
• Body Mass Index (BMI) [Time frame: From enrollment to 90-day follow-up]
• Gastrointestinal Symptom Rating Scale (GSRS) [Time frame: From enrollment to 90-day follow-up]
• Incidence of Gastrointestinal Adverse Events [Time frame: From enrollment to hospital discharge (up to 90 days)]
• Serum Total Bile Acids Level [Time frame: From enrollment to hospital discharge (up to 90 days)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

China · 12 centers

• The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine — Fuzhou
• Quanzhou First Hospital, Fujian — Quanzhou
• Guangdong Hospital of Traditional Chinese Medicine — Guangzhou
• Guangzhou Medical University Affiliated Panyu Central Hospital — Guangzhou
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
• The Affiliated Qingyuan People's Hospital of Guangzhou Medical University — Qingyuan
• Affiliated Hospital of Guangdong Medical University — Zhanjiang
• Changhai Hospital — Shanghai
• … and 4 more centers

Identifiers

NCT: NCT07464392 · KTSB20250907011

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗