Acute Pancreatitis, Fecal Microbiota Transplantation, Intestinal Bacteria Flora Disturbance, Intestinal Dysfunction
Conditions
Keywords
acute pancreatitis, intestinal mucosal barrier, Fecal Microbiota Transplantation
Brief summary
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
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.
Interventions
OTHERFecal Microbiota Transplantation
Fecal Microbiota Transplantation and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 1
OTHERnormal saline
normal saline and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 2
Sponsors
First Affiliated Hospital of Chengdu Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality | 3 months |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactLi Fang, Ph.D
Backup ContactYan Zhou, Ph.D
Outcome results
None listed