Randomized, Double-blind Clinical Trial on the Efficacy and Safety of Gut Microbiota Transplantation (FMT) in the Treatment of Moderate to Severe Acute Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pancreatic infectious complications
研究概览
简要总结
This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT in patients with moderate to severe acute pancreatitis.
详细描述
This study is a single center, randomized controlled trial. After the start of the study, 80 patients with acute moderate to severe acute pancreatitis were randomly selected according to inclusion and exclusion criteria and divided into an intervention group (n=40) and a control group (n=40) to explore the safety and efficacy of FMT in preventing late complications of acute moderate to severe acute pancreatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-70 years old Diagnosis: Meets the diagnostic criteria for severe acute pancreatitis (SAP)
- •Organ function: There may be organ failure and systemic complications that can be recovered within 48 hours
- •Stage of the disease: Approximately 2 weeks after onset (non acute phase), accompanied by accumulation of pancreatic fluid volume, and significant improvement in CTSI score compared to before (grade II)
- •Nutritional support: Enteral nutrition tube has been left in place Feasibility of transplantation: No absolute contraindications for gut microbiota transplantation
- •Informed Consent: Voluntarily sign a written informed consent form
- •Gastrointestinal status:
- •Abdominal pressure (bladder pressure measurement)<12mmHg ◦ Existence of spontaneous defecation/exhaust Significant improvement in abdominal distension compared to before
排除标准
- •Serious complications: combined gastrointestinal bleeding or intestinal fistula
- •Special population: Pregnant or lactating women
- •Informed refusal: Failure to sign informed consent form
- •Basic organ dysfunction: Prior to admission, there were chronic organ dysfunction in the heart, lungs, liver, kidneys, or blood system Malignant tumor: Suffering from incurable malignant tumors
- •Immune abnormalities:
- •Autoimmune diseases
- •◦ Immunosuppression status (solid organ/bone marrow transplantation history, AIDS, long-term use of immunosuppressants/hormones)
- •Enteral nutrition intolerance: unable to meet 50% of calorie requirements due to severe diarrhea, fibrotic intestinal stenosis, severe gastrointestinal edema, high flow intestinal fistula, etc
- •Systemic infection: meets the diagnostic criteria for systemic inflammatory response syndrome (SIRS)
- •Antibiotic dependence: broad-spectrum antibiotic intervention is required for combined extraintestinal organ infections
- •Immunodeficiency: Congenital or acquired immunodeficiency
- •Mental illness: severe mental disorders
研究组 & 干预措施
Placebo
Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.
干预措施: Placebo (Procedure)
FMT
FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days.
After intestinal preparation (via nasal feeding of inulin or oligofructose 24 hours before FMT), the subjects underwent 5-6 consecutive FMT treatments (injecting 100ml of standard bacterial solution 1/d into the nasojejunal nutrition tube, with a minimum of 2.5 * 1012 CFU of viable cells per 50mL of bacterial solution).
FMT intervention can be performed when the subject's intestinal function is restored and SIRS indicators are significantly relieved compared to before.
During the research period, long-term use of probiotics, antibiotics, and other foods and drugs that interfere with and damage gut microbiota is prohibited. Subjects need to be informed in advance before taking any medication.
All subjects need to complete relevant examinations before enrollment. Conduct a comprehensive safety and efficacy evaluation during treatment, after treatment, and one week after treatment.
干预措施: FMT (Procedure)
结局指标
主要结局
Pancreatic infectious complications
时间窗: through study completion, an average of 1 year
Infectious pancreatic necrosis, sepsis, and pancreatic fistula. Infectious pancreatic necrosis: (1) Imaging suggests the formation of gas at the site of necrosis aggregation; (2) Gram staining or culture positivity of necrotic specimens obtained through percutaneous fine needle aspiration (FNAC); (3) Clinically suspected infection symptoms. However, due to the high false positive rate, routine FNAC examination is not recommended. Sepsis: (1) Two blood cultures (or bone marrow cultures) are positive for the same pathogen. (2) Systemic inflammatory response syndrome (SIRS) occurs. Pancreatic fistula: (1) History of acute necrotizing pancreatitis attacks; (2) Imaging supports the diagnosis of pancreatic fistula. Measurement: Yes/No (incidence rate)
次要结局
- Inflammatory markers(Up to 3 months)
- Change in CTSI score(through study completion, an average of 1 year)
- Changes in gut microbiome community(Up to 1 week)
- Gastrointestinal mucosal barrier index(Up to 1 weeks)
- Markers of inflammatory conditions(Up to 3 months)
研究者
Xiangyu Kong
Principle Investigator
Changhai Hospital