Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Infectious Complications

Conditions
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Acute Pancreatitis, Fecal Microbiota Transplantation, Bacterial Translocation, Infectious Complications

Intervention / Treatment
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* Procedure: Fecal Microbiota Transplantation
* Drug: The traditional treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: SAP complicated by Gastrointestinal bleeding or Intestinal fistula Pregnancy and lactation women Not signed the informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal Microbiota Transplantation<br>FMT by retention enema with fresh bacteria from healthy donor，At the same time give patients the traditional treatment of SAP | Procedure: Fecal Microbiota Transplantation<br>* FMT by retention enema with fresh bacteria from healthy donor<br>* Other names: Fecal Transplantation;Drug: The traditional treatment<br>* the traditional treatments according to associated guidelines<br>* Other names: Conventional drugs according to the guideline;|
| Other: The traditional treatment<br>The traditional treatment of SAP according to the associated guidelines | Drug: The traditional treatment<br>* the traditional treatments according to associated guidelines<br>* Other names: Conventional drugs according to the guideline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The control of infectious complications | The temperature recovered to normal for 3 days. The inflammatory cytokines decreased to the normal value. | From admission to discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein（CRP）level | C-reactive protein (CRP) is a inflammatory prognostic marker | 1day before intervention，7days and 14days after intervention | 
| Procalcitionin（PCT）level | Procalcitionin（PCT）level is a inflammatory prognostic marker | 1day before intervention，7days and 14days after intervention | 
| Length of Intensive care time and hospital stay | The time of stay in the intensive care unit and hospital | From admission to discharge | 
| Mortality | The incidence of death during the time frame | From admission to discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal Microbiota Transplantation, Severe acute pancreatitis, Bacterial Translocation, Infectious Complications