Fecal Microbiota Transplantation (FMT) for Severe Acute Pancreatitis(SAP)

Study Overview
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Brief Summary
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Severe acute pancreatitis is an acute and rapid progress of the digestive system disease.Most patients with severe pancreatitis associated with intestinal mucosal barrier dysfunction.Intestinal microflora,an important part of the intestinal mucosal barrier, play an important role in the development process in the course of severe acute pancreatitis. At this stage of the study that infection of pancreas and other organs is the leading cause of death in patients with severe acute pancreatitis，and the main pathogens from intestinal micro-organisms， but the intestinal flora changes did not be mentioned. Fecal Microbiota Transplantation that has been used for treatment of inflammatory bowel disease and Clostridium difficile infection may be a new technology for regulation of intestinal mucosal dysfunction and intestinal flora unbalance.

Detailed Description
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Patients with acute pancreatitis will be assessed depending on APACHE II and CT score and all of them also will be separated into two parts depending on acceptation or refusal of FMT. Blood specimens from patients will be collected to analysis inflammatory factors，and fecal microbiota samples will be detection.

Official Title
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Alteration of Intestinal Microflora and Efficacy and Safety of Fecal Microbiota Transplantation for Severe Acute Pancreatitis

Conditions
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Acute Pancreatitis, Intestinal Bacteria Flora Disturbance, Intestinal Dysfunction, Fecal Microbiota Transplantation

Intervention / Treatment
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* Other: Fecal Microbiota Transplantation
* Other: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of acute pancreatitis: elevated serum amylase and/or lipase levels (more than 3-fold the upper reference limit) and evidence of pancreatitis on computed tomography (CT) of the abdomen; No chronic diseases of the digestive system ; No chronic diseases of the urinary system; No chronic metabolic disease; No chronic disease of immune system No chronic disease of mental disease no acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month; No use of addictive drugs and immune inhibitors Exclusion Criteria: not to match the standard of AP with chronic diseases of the digestive system; with chronic diseases of the urinary system; with chronic metabolic disease; with chronic disease of immune system with chronic disease of mental disease with acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;pregnancy and lactation women with use of addictive drugs and immune inhibitors exceed the age limits

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment for part 1<br>Fecal Microbiota Transplantation (FMT) and traditional treatments according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 1. | Other: Fecal Microbiota Transplantation<br>* Fecal Microbiota Transplantation and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 1<br>* Other names: Fecal Microbiota Transplantation (FMT);|
| Placebo Comparator: Placebo for part 2<br>The traditional treatments and normal saline (NS) according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 2. | Other: normal saline<br>* normal saline and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 2<br>* Other names: normal saline (NS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein（CRP） |  | 2-4 weeks | 
| Diamine oxidase（DAO） |  | 2-4 weeks | 
| Interleukin |  | 2-4 weeks | 
| tumor necrosis factor-a(TNF-a) |  | 2-4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute pancreatitis, intestinal mucosal barrier, Fecal Microbiota Transplantation