Fecal Microbiota Transplantation for Pancreatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Intestinal Barrier Dysfunction

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

Intervention / Treatment
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* Procedure: Fecal Microbiota Transplantation
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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.

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: FMT group<br>In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube. | Procedure: Fecal Microbiota Transplantation<br>* FMT via a nasoduodenal tube with fresh bacteria from healthy donor<br>* Other names: Fecal Transplantation;|
| Placebo Comparator: Control group<br>In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube. | Drug: normal saline<br>* Normal saline via a nasoduodenal tube.<br>* Other names: normal saline 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Gastrointestinal Failure Score Equal 0 | 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. | one week after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Infectious Complications | The incidence of any infectious complications，such as infected pancreatic necrosis, infected ascites, bacteraemia, pneumonia, urinary tract infection. | 120 days | 
| Number of Participants With Organ Failure | The incidence of organ failure,such as respiratory failure, renal failure, circulatory failure. | 120 days | 
| Number of Participants With Interventions or Surgery | number of patients who need extra interventions or surgery | 120 days | 
| Length of Intensive Care Time and Hospital Stay | patients' Length of Intensive care time and hospital stay due to the disease | 6 months | 
| Mortality | patients who die due to the diseases | 120 days | 
| Diamine Oxidase（DAO） | 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) | one week after intervention | 
| D-lactate | 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). | one week after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe acute pancreatitis, Fecal Microbiota Transplantation, Intestinal barrier dysfunction, Intestinal flora