Overview

Fecal Microbiota Transplantation for Pancreatitis

Status:
Completed
Trial end date:
2019-12-18
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The First Affiliated Hospital of Nanchang University
Criteria
Inclusion Criteria:

1. 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

2. Onset of pancreatitis within <=2 weeks

3. 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:

1. SAP complicated by Gastrointestinal bleeding or Intestinal fistula

2. Pregnancy and lactation women

3. Not signed the informed consent

4. Diabetes and autoimmune diseases

5. 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.