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

Phase 1

• Conditions: Fecal Microbiota Transplantation; Acute Pancreatitis; Intestinal Bacteria Flora Disturbance; Intestinal Dysfunction
• Interventions: Other: normal saline; Other: Fecal Microbiota Transplantation

• Registration Number: NCT03015467
• Lead Sponsor: First Affiliated Hospital of Chengdu Medical College

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.

Study Timeline

• Study Start: 2016-12
• Status Verified: 2017-01
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-10
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11
• Primary Completion: 2019-12
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo for part 2	normal saline	The traditional treatments and normal saline (NS) according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 2.
treatment for part 1	Fecal Microbiota Transplantation	Fecal Microbiota Transplantation (FMT) and traditional treatments according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 1.

Primary Outcome Measures

Name	Time	Method
Mortality	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IEC of Chengdu Medical College; 🇨🇳 Chendu, China