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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- Incidence of Infectious Complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Fecal Microbiota Transplantation
Fecal microbiota transplantation (FMT) liquid, 100 mL , administered via nasojejunal tube, once daily for 5 consecutive days, plus standard treatment.
干预措施: Fecal Microbiota Transplantation (Biological)
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.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Infectious Complications
时间窗: Within 30 days after enrollment
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.
次要结局
- Incidence of Infectious Complications(Within 90 days after enrollment)
- Organ Failure(From enrollment to hospital discharge (up to 90 days))
- Enteral Nutrition Caloric Intake(From enrollment to hospital discharge (up to 90 days))
- NUTRIC Score(From enrollment to hospital discharge (up to 90 days))
- Hospital Length of Stay(From enrollment to hospital discharge (up to 90 days))
- Subjective Global Assessment (SGA)(Baseline, Day 30, Day 60, Day 90)
- Serum Nutritional Protein Markers(From enrollment to hospital discharge (up to 90 days))
- Serum Prealbumin(From enrollment to hospital discharge (up to 90 days))
- Serum Electrolyte Levels(From enrollment to hospital discharge (up to 90 days))
- Body Mass Index (BMI)(From enrollment to 90-day follow-up)
- Gastrointestinal Symptom Rating Scale (GSRS)(From enrollment to 90-day follow-up)
- Incidence of Gastrointestinal Adverse Events(From enrollment to hospital discharge (up to 90 days))
- Serum Total Bile Acids Level(From enrollment to hospital discharge (up to 90 days))
- Serum Diamine Oxidase (DAO) Level(From enrollment to hospital discharge (up to 90 days))
- Serum Endotoxin Level(From enrollment to hospital discharge (up to 90 days))
- Serum D-Lactate Level(From enrollment to hospital discharge (up to 90 days))
- Gut Microbiota Changes(Baseline, Day 7, Day 30, Day 90)
- Need for Additional Interventions or Surgery(From treatment initiation to 90-day follow-up)
- Mortality(From enrollment to 90-day follow-up)
- Antibiotic Utilization(From hospital admission to 90-day follow-up)
研究者
Xiangyu Kong
Associate Professor
Changhai Hospital