Fecal Microbiota Transplantation for Pancreatitis

Phase 2

Completed

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

Interventions: Drug: normal saline
Procedure: Fecal Microbiota Transplantation

Brief Summary: The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis and protecting the gut against pathogens by competing for nutrients, creating the intestinal biological barrier and modulating the host immune system.After the onset of acute pancreatitis,the intestinal hypoperfusion and the release of inflammatory mediators result in intestinal barrier dysfunction and intestinal bacteria dysbiosis.This leads to Bacterial and endotoxin translocation, which may cause infectious complications which are major causes of death in SAP patients.Recently,FMT was shown its efficacy in the treatment of gastrointestinal(GI) diseases and non-GI disorders associated with Intestinal flora disturbance by re-establishing the damaged Intestinal Bacteria homeostasis.However,the mechanism by which FMT results in cure of diseases has been poorly understood.This study aims to investigate the therapeutic potential of FMT for SAP patients with intestinal barrier dysfunction.

Detailed Description: Investigators aims to restore the intestinal bacteria homeostasis through FMT by retention enema with fresh bacteria,thus stabilizing intestinal barrier dysfunction,minimizing bacterial translocation and preventing infectious complications.The investigators will further examine the effect of FMT on inflammatory markers，the predictors of Intestinal barrier injury and the incidence of infectious complications.

Recruitment & Eligibility

Inclusion Criteria

Diagnosis of 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 within <=2 weeks
complicated with gastrointestinal failure. Gastrointestinal failure was defined if the patients were complicated with obvious abdominal distention, abdominal rumbling sound weakening or disappearance, no self-defecation as well as intra-abdominal hypertension.

Exclusion Criteria

SAP complicated by Gastrointestinal bleeding or Intestinal fistula
Pregnancy and lactation women
Not signed the informed consent
Diabetes and autoimmune diseases
Multiple organ failure. Organ failure was defined as a score of 2 or more using the modified Marshall scoring system including respiratory failure, renal failure and circulatory.

Arm && Interventions

Group	Intervention	Description
Control group	normal saline	In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
FMT group	Fecal Microbiota Transplantation	In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Gastrointestinal Failure Score Equal 0	one week after intervention	The recovery of gastrointestinal dysfunction was assessed by gastrointectinal failure score. Gastrointestinal failure score is a comprehensive score for assessing gastrointestinal function. Gastrointestinal dysfunction score gets o point meaning enteral nutrition\> 50% of the required amount and no intra-abdominal hypertension. GIF score range from 0 to 4, and higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Infectious Complications	120 days	The incidence of any infectious complications，such as infected pancreatic necrosis, infected ascites, bacteraemia, pneumonia, urinary tract infection.
Number of Participants With Organ Failure	120 days	The incidence of organ failure,such as respiratory failure, renal failure, circulatory failure.
Number of Participants With Interventions or Surgery	120 days	number of patients who need extra interventions or surgery
Length of Intensive Care Time and Hospital Stay	6 months	patients' Length of Intensive care time and hospital stay due to the disease
Mortality	120 days	patients who die due to the diseases
Diamine Oxidase（DAO）	one week after intervention	Plasma Diamine oxidase（DAO）level as a predictor in the diagnosis of Intestinal mucosal barrier injury. The rate of decline in DAO was calculated by ((value before intervention - value one week after intervention)/ value before intervention)\*100)
D-lactate	one week after intervention	Plasma D-lactate level as a predictor in the diagnosis of Intestinal mucosal. The rate of decline in D-lactate was calculated by ((value before intervention - value one week after intervention)/ value before intervention)\*100).