Acute Pancreatitis, Bacterial Translocation, Fecal Microbiota Transplantation, Infectious Complications
Conditions
Keywords
Severe acute pancreatitis, Fecal Microbiota Transplantation, Bacterial Translocation, Infectious Complications
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREFecal Microbiota Transplantation
FMT by retention enema with fresh bacteria from healthy donor
DRUGThe traditional treatment
the traditional treatments according to associated guidelines
Sponsors
The First Affiliated Hospital of Nanchang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. Onset of pancreatitis more than 2 weeks 3. Intestinal bacterium screening tips gut dysbacteriosis 4. Patients with symptoms of infection, such as fever, abdominal pain or blood culture and pancreatic necrosis drainage culture positive patients.
Exclusion criteria
1. SAP complicated by Gastrointestinal bleeding or Intestinal fistula 2. Pregnancy and lactation women 3. Not signed the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The control of infectious complications | From admission to discharge | The temperature recovered to normal for 3 days. The inflammatory cytokines decreased to the normal value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein（CRP）level | 1day before intervention，7days and 14days after intervention | C-reactive protein (CRP) is a inflammatory prognostic marker |
| Procalcitionin（PCT）level | 1day before intervention，7days and 14days after intervention | Procalcitionin（PCT）level is a inflammatory prognostic marker |
| Length of Intensive care time and hospital stay | From admission to discharge | The time of stay in the intensive care unit and hospital |
| Mortality | From admission to discharge | The incidence of death during the time frame |
Countries
China
Contacts
Primary ContactYin Zhu, MD
Backup ContactLingyu Luo, MD
Outcome results
None listed