Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Infectious Complications
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The control of infectious complications
研究概览
简要总结
Infectious complications are responsible for most of deaths in acute pancreatitis.Intestinal barrier dysfunction and increased intestinal permeability was associated with bacterial translocation which is believed to prompted these infections.The purpose of this clinical trail is to observe the potential capability of FMT in reduce the bacterial translocation and alleviate infectious complications by the reconstruction of a gut functional state.
详细描述
Investigators aims to restore the intestinal bacteria homeostasis through FMT by retention enema with fresh bacteria,thus minimizing bacterial translocation and alleviating infectious complications. The investigators will further examine the effect of FMT on the incidence of infectious complications，duration of clinical course and mortality.
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
- Single (Participant)
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
- •Diagnosis of severe acute pancreatitis from the First Affiliated Hospital of Nanchang University according to the Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus
- •Onset of pancreatitis more than 2 weeks
- •Intestinal bacterium screening tips gut dysbacteriosis
- •Patients with symptoms of infection, such as fever, abdominal pain or blood culture and pancreatic necrosis drainage culture positive patients.
排除标准
- •SAP complicated by Gastrointestinal bleeding or Intestinal fistula
- •Pregnancy and lactation women
- •Not signed the informed consent
研究组 & 干预措施
Fecal Microbiota Transplantation
FMT by retention enema with fresh bacteria from healthy donor，At the same time give patients the traditional treatment of SAP
干预措施: Fecal Microbiota Transplantation (Procedure)
Fecal Microbiota Transplantation
FMT by retention enema with fresh bacteria from healthy donor，At the same time give patients the traditional treatment of SAP
干预措施: The traditional treatment (Drug)
The traditional treatment
The traditional treatment of SAP according to the associated guidelines
干预措施: The traditional treatment (Drug)
结局指标
主要结局
The control of infectious complications
时间窗: From admission to discharge
The temperature recovered to normal for 3 days. The inflammatory cytokines decreased to the normal value.
次要结局
- C-reactive protein（CRP）level(1day before intervention，7days and 14days after intervention)
- Procalcitionin（PCT）level(1day before intervention，7days and 14days after intervention)
- Length of Intensive care time and hospital stay(From admission to discharge)
- Mortality(From admission to discharge)
研究者
Lingyu Luo
Physician-in-charge
The First Affiliated Hospital of Nanchang University