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

First Affiliated Hospital of Chengdu Medical College80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Pancreatitis Intestinal Bacteria Flora Disturbance

Interventions

Fecal Microbiota TransplantationOTHER

Fecal Microbiota Transplantation and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 1

normal salineOTHER

normal saline and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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; 2. No chronic diseases of the digestive system ; 3. No chronic diseases of the urinary system; 4. No chronic metabolic disease; 5. No chronic disease of immune system 6. No chronic disease of mental disease 7. no acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month; 8. No use of addictive drugs and immune inhibitors Exclusion Criteria: 1. not to match the standard of AP 2. with chronic diseases of the digestive system; 3. with chronic diseases of the urinary system; 4. with chronic metabolic disease; 5. with chronic disease of immune system 6. with chronic disease of mental disease 7. with acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;pregnancy and lactation women 8. with use of addictive drugs and immune inhibitors 9. exceed the age limits

Outcomes

Primary Outcomes

Mortality

Time frame: 3 months

Secondary Outcomes

C-reactive protein（CRP）

Time frame: 2-4 weeks

Diamine oxidase（DAO）

Time frame: 2-4 weeks

Interleukin

Time frame: 2-4 weeks

tumor necrosis factor-a(TNF-a)

Time frame: 2-4 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts